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Trial record 55 of 1317 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression

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ClinicalTrials.gov Identifier: NCT01098240
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : April 2, 2010
Results First Posted : June 26, 2013
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: CP-601,927
Other: Placebo
Enrollment 297
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Antidepressant Treatment (ADT) CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase. Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase. Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Period Title: Open-Label Phase
Started 297 0 0
Completed 162 0 0
Not Completed 135 0 0
Reason Not Completed
Study Terminated by Sponsor             27             0             0
Protocol Violation             4             0             0
Lost to Follow-up             13             0             0
Other             19             0             0
Did Not Meet Entrance Criteria             50             0             0
Pregnancy             1             0             0
Withdrawal by Subject             9             0             0
Adverse Event             12             0             0
Period Title: Double-Blind Phase
Started 0 77 85
Completed 0 60 63
Not Completed 0 17 22
Reason Not Completed
Study Terminated by Sponsor             0             5             8
Protocol Violation             0             2             4
Lost to Follow-up             0             2             0
Other             0             2             2
Did Not Meet Entrance Criteria             0             1             0
Insufficient Clinical Response             0             1             2
Withdrawal by Subject             0             1             3
Adverse Event             0             3             3
Arm/Group Title Open-Label ADT
Hide Arm/Group Description Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
Overall Number of Baseline Participants 297
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 297 participants
18 to 44 years 113
45 to 64 years 181
Greater than or equal to (>=) 65 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants
Female
220
  74.1%
Male
77
  25.9%
1.Primary Outcome
Title Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
Hide Description MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
Time Frame Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 29.5  (6.00) 29.1  (5.54)
Change at week 14 (n=62,63) -10.3  (8.60) -8.8  (10.40)
2.Secondary Outcome
Title Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13
Hide Description MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
Time Frame Week 8 (double-blind baseline) and weeks 9 through 13
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 29.5  (6.00) 29.1  (5.54)
Change at week 9 (n=76,82) -2.4  (4.68) -3.3  (5.35)
Change at week 10 (n=71,80) -4.7  (6.65) -4.6  (6.85)
Change at week 11 (n=67,71) -7.0  (7.78) -6.0  (8.06)
Change at week 12 (n=64,73) -8.5  (8.08) -7.4  (8.83)
Change at week 13 (n=65,68) -8.6  (8.16) -7.9  (9.37)
3.Secondary Outcome
Title Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14
Hide Description The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).
Time Frame Weeks 8 (double-blind baseline) through 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 26.4  (4.25) 26.3  (4.96)
Change at week 9 (n=76,82) -3.0  (4.49) -3.0  (5.25)
Change at week 10 (n=71,80) -4.4  (6.57) -4.7  (5.78)
Change at week 11 (n=67,71) -5.9  (7.40) -6.4  (7.06)
Change at week 12 (n=64,73) -7.6  (7.63) -6.7  (7.67)
Change at week 13 (n=65,68) -8.0  (7.22) -7.3  (7.90)
Change at week 14 (n=62,63) -9.1  (7.76) -8.4  (8.99)
4.Secondary Outcome
Title Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14
Hide Description The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.
Time Frame Weeks 8 (double-blind baseline) through 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 11.6  (1.90) 11.6  (2.05)
Change at week 9 (n=76,82) -1.3  (2.31) -1.5  (2.48)
Change at week 10 (n=71,80) -2.1  (3.07) -2.0  (2.87)
Change at week 11 (n=67,71) -3.0  (3.55) -2.7  (3.38)
Change at week 12 (n=64,73) -3.6  (3.65) -3.0  (3.40)
Change at week 13 (n=65,68) -3.8  (3.56) -3.2  (3.69)
Change at week 14 (n=62,63) -4.3  (3.87) -3.7  (4.15)
5.Secondary Outcome
Title Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14
Hide Description CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.
Time Frame Week 8 (double-blind baseline) and weeks 9, 10, 12, 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 4.2  (0.59) 4.2  (0.67)
Change at week 9 (n=76,82) -0.2  (0.49) -0.2  (0.60)
Change at week 10 (n=71,80) -0.5  (0.81) -0.5  (0.83)
Change at week 12 (n=64,72) -0.8  (1.01) -0.7  (1.14)
Change at week 14 (n=62,63) -1.1  (1.11) -1.0  (1.18)
6.Secondary Outcome
Title Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14
Hide Description The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.
Time Frame Weeks 8 (double-blind baseline), 11 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,84) 36.1  (13.21) 34.8  (13.68)
Change at week 11 (n=66,71) -9.3  (14.41) -7.3  (13.70)
Change at week 14 (n=62,62) -12.3  (15.80) -10.4  (17.11)
7.Secondary Outcome
Title Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14
Hide Description SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).
Time Frame Weeks 8 (double-blind baseline), 11 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=61,68) 19.0  (5.88) 18.5  (5.30)
Change at week 11 (n=45,52) -5.6  (6.98) -3.8  (6.33)
Change at week 14 (n=41,44) -6.6  (7.98) -5.7  (8.21)
8.Secondary Outcome
Title Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14
Hide Description SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).
Time Frame Weeks 8 (double-blind baseline), 11 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=61,68) 6.0  (2.22) 5.5  (2.66)
Change at week 11 (n=45,52) -2.1  (2.86) -0.9  (2.10)
Change at week 14 (n=41,44) -2.1  (2.88) -1.9  (2.66)
9.Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14
Hide Description CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Weeks 8 (double-blind baseline) 9, 10, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (double-blind baseline) (n=77,85) 3.7  (0.77) 3.5  (0.66)
Week 9 (n=76,82) 3.4  (0.84) 3.2  (0.78)
Week 10 (n=71,80) 3.2  (0.92) 3.1  (0.88)
Week 12 (n=64,72) 2.7  (1.05) 2.8  (1.07)
Week 14 (n=62,63) 2.5  (1.05) 2.7  (1.03)
10.Secondary Outcome
Title Number of Participants With Remission at Weeks 9, 10, 12 and 14
Hide Description Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 (’much’ or ’very much’ improved).
Time Frame Weeks 9, 10, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 76 82
Measure Type: Number
Unit of Measure: Participants
Week 9 (n=76,82) 1 0
Week 10 (n=71,80) 4 1
Week 12 (n=64,72) 5 9
Week 14 (n=62,63) 9 11
11.Secondary Outcome
Title Number of Participants With Response at Weeks 9 Through 14
Hide Description Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.
Time Frame Weeks 9 through 14
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 76 82
Measure Type: Number
Unit of Measure: Participants
Week 9 (n=76,82) 3 4
Week 10 (n=71,80) 8 8
Week 11(n=67,71) 15 10
Week 12 (n=64,73) 18 16
Week 13 (n=65,68) 23 20
Week 14 (n=62,63) 22 20
12.Secondary Outcome
Title Population Pharmacokinetics
Hide Description Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations
Time Frame Weeks 11,12 and 14
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Plasma CP-601,927 Concentration
Hide Description Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.
Time Frame Week 11, 12 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with at least one dose of study medication in DB (double blind) phase and one valid plasma concentration measurement collected during the DB phase was be included in the analyses of the PK endpoints. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 11 at 1 Hour (n=53) 5.80  (3.42)
Week 11 at 2 Hour (n=53) 5.90  (3.13)
Week 12 (n=56) 6.24  (3.85)
Week 14 at 1 Hour (n=60) 5.36  (3.83)
Week 14 at 2 Hour (n=57) 5.39  (3.89)
14.Other Pre-specified Outcome
Title The Sheehan Suicidality Tracking Scale (STS)
Hide Description The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.
Time Frame Week 8 (double-blind baseline) and weeks 9 through 14
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Hide Analysis Population Description
The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.
Arm/Group Title CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description:
Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
Overall Number of Participants Analyzed 77 85
Measure Type: Number
Unit of Measure: Participants
Week 8 (n=77,85), suicidal ideation 11 13
Week 8 (n=77,85), no suicidal behavior and risk 66 72
Week 9 (n=72,79), suicidal ideation 10 8
Week 9 (n=72,79), self-injurious, no intent 1 0
Week 9 (n=72,79), no suicidal behavior and risk 61 71
Week 10 (n=69,74), suicidal ideation 12 7
Week 10 (n=69,74), no suicidal behavior and risk 57 67
Week 11 (n=64,71), suicidal ideation 8 5
Week 11 (n=64,71), no suicidal behavior and risk 56 66
Week 12 (n=63,70), suicidal ideation 6 5
Week 12 (n=63,70), no suicidal behavior and risk 57 65
Week 13 (n=62,63), suicidal ideation 5 5
Week 13 (n=62,63), no suicidal behavior and risk 57 58
Week 14 (n=75,81), suicidal ideation 5 6
Week 14 (n=75,81), no suicidal behavior and risk 70 75
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Open-Label ADT CP-601,927 + ADT Placebo + ADT
Hide Arm/Group Description Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase. Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase. Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
All-Cause Mortality
Open-Label ADT CP-601,927 + ADT Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label ADT CP-601,927 + ADT Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/297 (1.01%)   1/77 (1.30%)   1/85 (1.18%) 
Cardiac disorders       
Atrial fibrillation * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Infections and infestations       
Pneumonia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid cancer  1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Psychiatric disorders       
Suicide attempt  1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Suicidal ideation * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-Label ADT CP-601,927 + ADT Placebo + ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   210/297 (70.71%)   58/77 (75.32%)   61/85 (71.76%) 
Cardiac disorders       
Palpitations * 1  4/297 (1.35%)  1/77 (1.30%)  0/85 (0.00%) 
Tachycardia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Ear and labyrinth disorders       
Cerumen impaction * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Ear pain * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Tinnitus * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Vertigo * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Eye disorders       
Conjunctivitis * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Vision blurred * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Visual impairment * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  5/297 (1.68%)  3/77 (3.90%)  0/85 (0.00%) 
Abdominal distension * 1  2/297 (0.67%)  0/77 (0.00%)  0/85 (0.00%) 
Abdominal pain * 1  3/297 (1.01%)  1/77 (1.30%)  1/85 (1.18%) 
Abdominal pain lower * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Abdominal pain upper * 1  6/297 (2.02%)  4/77 (5.19%)  1/85 (1.18%) 
Abdominal tenderness * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Constipation * 1  11/297 (3.70%)  2/77 (2.60%)  3/85 (3.53%) 
Dental caries * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Diarrhoea * 1  28/297 (9.43%)  4/77 (5.19%)  5/85 (5.88%) 
Dry mouth * 1  17/297 (5.72%)  4/77 (5.19%)  8/85 (9.41%) 
Dyspepsia * 1  6/297 (2.02%)  3/77 (3.90%)  1/85 (1.18%) 
Dysphagia * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Eructation * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Faeces discoloured * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Flatulence * 1  7/297 (2.36%)  1/77 (1.30%)  0/85 (0.00%) 
Gastrointestinal disorder * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Gastrointestinal pain * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Gastrointestinal sounds abnormal * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Gastrooesophageal reflux disease * 1  3/297 (1.01%)  1/77 (1.30%)  0/85 (0.00%) 
Gingival swelling * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Haemorrhoids * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Hiatus hernia * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Nausea * 1  39/297 (13.13%)  11/77 (14.29%)  12/85 (14.12%) 
Oesophageal obstruction * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Rectal haemorrhage * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Tongue cyst * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Toothache * 1  3/297 (1.01%)  0/77 (0.00%)  2/85 (2.35%) 
Vomiting * 1  3/297 (1.01%)  2/77 (2.60%)  1/85 (1.18%) 
General disorders       
Asthenia * 1  2/297 (0.67%)  1/77 (1.30%)  1/85 (1.18%) 
Chills * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Drug withdrawal syndrome * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Fatigue * 1  18/297 (6.06%)  3/77 (3.90%)  13/85 (15.29%) 
Feeling abnormal * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Feeling hot * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Feeling jittery * 1  3/297 (1.01%)  1/77 (1.30%)  0/85 (0.00%) 
Influenza like illness * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Irritability * 1  12/297 (4.04%)  2/77 (2.60%)  5/85 (5.88%) 
Local swelling * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Oedema peripheral * 1  4/297 (1.35%)  1/77 (1.30%)  0/85 (0.00%) 
Pain * 1  2/297 (0.67%)  1/77 (1.30%)  0/85 (0.00%) 
Pyrexia * 1  4/297 (1.35%)  0/77 (0.00%)  0/85 (0.00%) 
Thirst * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Hepatobiliary disorders       
Biliary colic * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Immune system disorders       
Hypersensitivity * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Multiple allergies * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Seasonal allergy * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Infections and infestations       
Abscess limb * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Bronchitis * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Cellulitis staphylococcal * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Conjunctivitis infective * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Fungal infection * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Gastroenteritis * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Gastroenteritis viral * 1  2/297 (0.67%)  0/77 (0.00%)  0/85 (0.00%) 
Gastrointestinal viral infection * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Gingival infection * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Herpes simplex * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Influenza * 1  6/297 (2.02%)  1/77 (1.30%)  2/85 (2.35%) 
Laryngitis * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Nasopharyngitis * 1  10/297 (3.37%)  2/77 (2.60%)  2/85 (2.35%) 
Oral infection * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Pharyngitis streptococcal * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Pneumonia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Respiratory tract infection * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Sinusitis * 1  5/297 (1.68%)  1/77 (1.30%)  2/85 (2.35%) 
Tooth abscess * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Tooth infection * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Upper respiratory tract infection * 1  24/297 (8.08%)  6/77 (7.79%)  4/85 (4.71%) 
Urinary tract infection * 1  6/297 (2.02%)  4/77 (5.19%)  2/85 (2.35%) 
Viral infection * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Vulvovaginal candidiasis * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Injury, poisoning and procedural complications       
Alcohol poisoning * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Arthropod bite * 1  2/297 (0.67%)  0/77 (0.00%)  0/85 (0.00%) 
Contusion * 1  3/297 (1.01%)  0/77 (0.00%)  1/85 (1.18%) 
Excoriation * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Fall * 1  1/297 (0.34%)  2/77 (2.60%)  1/85 (1.18%) 
Foot fracture * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Fractured coccyx * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Fractured sacrum * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Hand fracture * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Laceration * 1  3/297 (1.01%)  0/77 (0.00%)  1/85 (1.18%) 
Ligament sprain * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Meniscus lesion * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Muscle strain * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Overdose * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Blood creatine phosphokinase increased * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Blood glucose decreased * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Blood glucose increased * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Blood pressure increased * 1  2/297 (0.67%)  1/77 (1.30%)  3/85 (3.53%) 
Colonoscopy * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Electrocardiogram QT prolonged * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Gamma-glutamyltransferase * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Liver function test abnormal * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Positive Rombergism * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Vitamin D decreased * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Weight decreased * 1  1/297 (0.34%)  2/77 (2.60%)  0/85 (0.00%) 
Weight increased * 1  0/297 (0.00%)  1/77 (1.30%)  1/85 (1.18%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  5/297 (1.68%)  3/77 (3.90%)  1/85 (1.18%) 
Dehydration * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Food craving * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Hyponatraemia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Increased appetite * 1  4/297 (1.35%)  1/77 (1.30%)  3/85 (3.53%) 
Vitamin D deficiency * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  3/297 (1.01%)  1/77 (1.30%)  2/85 (2.35%) 
Back pain * 1  3/297 (1.01%)  1/77 (1.30%)  5/85 (5.88%) 
Flank pain * 1  2/297 (0.67%)  1/77 (1.30%)  0/85 (0.00%) 
Muscle disorder * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Muscle spasms * 1  1/297 (0.34%)  2/77 (2.60%)  1/85 (1.18%) 
Muscle tightness * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Muscle twitching * 1  2/297 (0.67%)  2/77 (2.60%)  0/85 (0.00%) 
Musculoskeletal chest pain * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Musculoskeletal pain * 1  2/297 (0.67%)  0/77 (0.00%)  2/85 (2.35%) 
Musculoskeletal stiffness * 1  3/297 (1.01%)  0/77 (0.00%)  0/85 (0.00%) 
Myalgia * 1  4/297 (1.35%)  2/77 (2.60%)  1/85 (1.18%) 
Neck pain * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Pain in extremity * 2  3/297 (1.01%)  1/77 (1.30%)  0/85 (0.00%) 
Pain in jaw * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Spondylitis * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Nervous system disorders       
Akathisia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Amnesia * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Aphasia * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Cognitive disorder * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Disturbance in attention * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Dizziness * 1  22/297 (7.41%)  5/77 (6.49%)  4/85 (4.71%) 
Dysgeusia * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Dyskinesia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Headache * 1  42/297 (14.14%)  16/77 (20.78%)  12/85 (14.12%) 
Hypersomnia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Hypoaesthesia * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Lethargy * 1  2/297 (0.67%)  1/77 (1.30%)  1/85 (1.18%) 
Memory impairment * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Migraine * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Neuralgia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Oromandibular dystonia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Paraesthesia * 1  4/297 (1.35%)  1/77 (1.30%)  0/85 (0.00%) 
Poor quality sleep * 1  2/297 (0.67%)  0/77 (0.00%)  0/85 (0.00%) 
Psychomotor hyperactivity * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Restless legs syndrome * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Retrograde amnesia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Sedation * 1  6/297 (2.02%)  1/77 (1.30%)  1/85 (1.18%) 
Sinus headache * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Somnolence * 1  18/297 (6.06%)  4/77 (5.19%)  4/85 (4.71%) 
Syncope * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Tension headache * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Tremor * 1  3/297 (1.01%)  2/77 (2.60%)  0/85 (0.00%) 
Psychiatric disorders       
Abnormal dreams * 1  3/297 (1.01%)  5/77 (6.49%)  3/85 (3.53%) 
Affective disorder * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Agitation * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Anger * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Anorgasmia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Anxiety * 1  8/297 (2.69%)  2/77 (2.60%)  1/85 (1.18%) 
Apathy * 1  2/297 (0.67%)  0/77 (0.00%)  1/85 (1.18%) 
Bruxism * 1  3/297 (1.01%)  0/77 (0.00%)  1/85 (1.18%) 
Depression * 1  4/297 (1.35%)  0/77 (0.00%)  1/85 (1.18%) 
Emotional disorder * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Initial insomnia * 1  3/297 (1.01%)  1/77 (1.30%)  1/85 (1.18%) 
Insomnia * 1  24/297 (8.08%)  10/77 (12.99%)  10/85 (11.76%) 
Libido decreased * 1  7/297 (2.36%)  1/77 (1.30%)  2/85 (2.35%) 
Mental status changes * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Middle insomnia * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Nervousness * 1  2/297 (0.67%)  1/77 (1.30%)  0/85 (0.00%) 
Nightmare * 1  0/297 (0.00%)  3/77 (3.90%)  2/85 (2.35%) 
Orgasm abnormal * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Panic attack * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Panic reaction * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Paranoia * 1  2/297 (0.67%)  0/77 (0.00%)  0/85 (0.00%) 
Personality disorder * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Restlessness * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Sleep disorder * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Sleep terror * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Suspiciousness * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Tachyphrenia * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Terminal insomnia * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Renal and urinary disorders       
Dysuria * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Micturition urgency * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Pollakiuria * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Reproductive system and breast disorders       
Ejaculation delayed * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Erection increased * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Menstruation delayed * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Polycystic ovaries * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Polymenorrhoea * 1  1/297 (0.34%)  0/77 (0.00%)  1/85 (1.18%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Cough * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Dry throat * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Dyspnoea * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Epistaxis * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Nasal congestion * 1  1/297 (0.34%)  2/77 (2.60%)  1/85 (1.18%) 
Oropharyngeal pain * 1  7/297 (2.36%)  0/77 (0.00%)  0/85 (0.00%) 
Respiratory tract congestion * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Rhinitis allergic * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Sinus congestion * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Yawning * 1  3/297 (1.01%)  2/77 (2.60%)  0/85 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne * 1  1/297 (0.34%)  2/77 (2.60%)  0/85 (0.00%) 
Dermatitis * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Hyperhidrosis * 1  5/297 (1.68%)  0/77 (0.00%)  1/85 (1.18%) 
Nail discolouration * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Night sweats * 1  0/297 (0.00%)  0/77 (0.00%)  1/85 (1.18%) 
Pruritus * 1  3/297 (1.01%)  2/77 (2.60%)  0/85 (0.00%) 
Rash * 1  1/297 (0.34%)  1/77 (1.30%)  1/85 (1.18%) 
Urticaria * 1  1/297 (0.34%)  1/77 (1.30%)  0/85 (0.00%) 
Surgical and medical procedures       
Colon polypectomy * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Vascular disorders       
Flushing * 1  1/297 (0.34%)  0/77 (0.00%)  0/85 (0.00%) 
Haematoma * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
Hot flush * 1  4/297 (1.35%)  0/77 (0.00%)  1/85 (1.18%) 
Hypertension * 1  2/297 (0.67%)  3/77 (3.90%)  0/85 (0.00%) 
Hypotension * 1  2/297 (0.67%)  2/77 (2.60%)  0/85 (0.00%) 
Orthostatic hypotension * 1  0/297 (0.00%)  1/77 (1.30%)  0/85 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
2
Term from vocabulary, MedDRA (v14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01098240     History of Changes
Other Study ID Numbers: A3331017
First Submitted: April 1, 2010
First Posted: April 2, 2010
Results First Submitted: September 18, 2012
Results First Posted: June 26, 2013
Last Update Posted: July 29, 2019