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Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01441440
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: venlafaxine ER 75 mg/day (fixed dose)
Drug: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
Drug: Placebo
Enrollment 538
Recruitment Details  
Pre-assignment Details Subjects were confirmed to meet entry criteria at the screening visit, followed by a 2-week screening period. Subjects who continued to meet all study entry criteria at baseline were randomized to 10 weeks of treatment with placebo, venlafaxine ER 75 mg/day Fixed, or venlafaxine ER 75-225 mg/day Flexible in the ratio of 1:1:1.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description Participants received placebo capsule orally once daily after meal for 8 weeks. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Period Title: Overall Study
Started 183 [1] 174 [1] 180 [1]
Completed 166 151 158
Not Completed 17 23 22
Reason Not Completed
Death             1             0             1
Adverse Event             2             9             9
Lost to Follow-up             0             2             1
Withdrawal by Subject             11             9             9
Pregnancy             1             0             0
Lack of Efficacy             1             0             1
Moving             0             1             1
Work-related matter             0             1             0
Difficllty in keeping the schedule             1             1             0
[1]
Safety analysis set
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible Total
Hide Arm/Group Description Participants received placebo capsule orally once daily after meal for 8 weeks. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8. Total of all reporting groups
Overall Number of Baseline Participants 184 174 179 537
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants 174 participants 179 participants 537 participants
38.6  (11.1) 38.4  (11.9) 38.3  (10.2) 38.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 174 participants 179 participants 537 participants
Female
93
  50.5%
90
  51.7%
86
  48.0%
269
  50.1%
Male
91
  49.5%
84
  48.3%
93
  52.0%
268
  49.9%
1.Primary Outcome
Title Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 184 174 177
Mean (Standard Error)
Unit of Measure: Units on a scale
-9.25  (0.48) -10.76  (0.50) -10.37  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.14 to 2.87
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
-0.24 to 2.48
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
2.Secondary Outcome
Title Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination
Hide Description MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 – 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 182 172 176
Mean (Standard Error)
Unit of Measure: Units on a scale
-12.41  (0.75) -15.30  (0.77) -15.05  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.88
Confidence Interval (2-Sided) 95%
0.77 to 5.00
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.64
Confidence Interval (2-Sided) 95%
0.54 to 4.74
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
3.Secondary Outcome
Title Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination
Hide Description CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 184 174 177
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.31  (0.08) -1.57  (0.08) -1.56  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.03 to 0.49
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.02 to 0.48
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
4.Secondary Outcome
Title Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination
Hide Description HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 184 174 177
Mean (Standard Error)
Unit of Measure: Units on a scale
-4.92  (0.28) -6.10  (0.29) -5.99  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.39 to 1.97
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.28 to 1.85
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
5.Secondary Outcome
Title Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination
Hide Description QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 182 172 175
Mean (Standard Error)
Unit of Measure: Units on a scale
-6.50  (0.36) -8.00  (0.37) -7.27  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.48 to 2.53
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
-0.25 to 1.79
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
6.Secondary Outcome
Title Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination
Hide Description CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Time Frame Baseline, Week 8 or Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description:
Participants received placebo capsule orally once daily after meal for 8 weeks.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
Overall Number of Participants Analyzed 184 174 177
Mean (Standard Error)
Unit of Measure: Units on a scale
2.53  (0.08) 2.32  (0.09) 2.28  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75 mg/Day Fixed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.02 to 0.45
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine 75-225 mg/Day Flexible
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.02 to 0.48
Estimation Comments Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Hide Arm/Group Description Participants received placebo capsule orally once daily after meal for 8 weeks. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8. Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
All-Cause Mortality
Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/183 (1.09%)   1/174 (0.57%)   1/180 (0.56%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/183 (0.55%)  0/174 (0.00%)  0/180 (0.00%) 
Ear and labyrinth disorders       
Meniere's disease * 1  0/183 (0.00%)  1/174 (0.57%)  0/180 (0.00%) 
Psychiatric disorders       
Completed suicide * 1  1/183 (0.55%)  0/174 (0.00%)  1/180 (0.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Venlafaxine 75 mg/Day Fixed Venlafaxine 75-225 mg/Day Flexible
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   98/183 (53.55%)   112/174 (64.37%)   131/180 (72.78%) 
Cardiac disorders       
Palpitations * 1  5/183 (2.73%)  8/174 (4.60%)  6/180 (3.33%) 
Tachycardia * 1  0/183 (0.00%)  4/174 (2.30%)  7/180 (3.89%) 
Ear and labyrinth disorders       
Vertigo * 1  2/183 (1.09%)  4/174 (2.30%)  6/180 (3.33%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  4/183 (2.19%)  7/174 (4.02%)  11/180 (6.11%) 
Abdominal pain upper * 1  7/183 (3.83%)  5/174 (2.87%)  0/180 (0.00%) 
Constipation * 1  8/183 (4.37%)  17/174 (9.77%)  17/180 (9.44%) 
Diarrhoea * 1  7/183 (3.83%)  6/174 (3.45%)  8/180 (4.44%) 
Dry mouth * 1  1/183 (0.55%)  5/174 (2.87%)  7/180 (3.89%) 
Nausea * 1  24/183 (13.11%)  39/174 (22.41%)  53/180 (29.44%) 
Vomiting * 1  7/183 (3.83%)  5/174 (2.87%)  4/180 (2.22%) 
General disorders       
Feeling abnormal * 1  0/183 (0.00%)  2/174 (1.15%)  4/180 (2.22%) 
Malaise * 1  5/183 (2.73%)  9/174 (5.17%)  11/180 (6.11%) 
Thirst * 1  14/183 (7.65%)  11/174 (6.32%)  18/180 (10.00%) 
Infections and infestations       
Nasopharyngitis * 1  41/183 (22.40%)  35/174 (20.11%)  32/180 (17.78%) 
Investigations       
Alanine aminotransferase increased * 1  0/183 (0.00%)  4/174 (2.30%)  2/180 (1.11%) 
Blood pressure increased * 1  2/183 (1.09%)  4/174 (2.30%)  5/180 (2.78%) 
Heart rate increased * 1  4/183 (2.19%)  10/174 (5.75%)  13/180 (7.22%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/183 (0.55%)  4/174 (2.30%)  4/180 (2.22%) 
Nervous system disorders       
Dizziness * 1  5/183 (2.73%)  10/174 (5.75%)  18/180 (10.00%) 
Dizziness postural * 1  1/183 (0.55%)  2/174 (1.15%)  5/180 (2.78%) 
Headache * 1  14/183 (7.65%)  16/174 (9.20%)  18/180 (10.00%) 
Somnolence * 1  15/183 (8.20%)  21/174 (12.07%)  31/180 (17.22%) 
Psychiatric disorders       
Insomnia * 1  6/183 (3.28%)  4/174 (2.30%)  8/180 (4.44%) 
Renal and urinary disorders       
Pollakiuria * 1  0/183 (0.00%)  2/174 (1.15%)  5/180 (2.78%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis * 1  2/183 (1.09%)  3/174 (1.72%)  15/180 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
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_Inuiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01441440     History of Changes
Other Study ID Numbers: B2411263
First Submitted: September 23, 2011
First Posted: September 27, 2011
Results First Submitted: March 2, 2015
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015