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A Study of CX157 (TriRima) for the Treatment of Depression (CX157-200)

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ClinicalTrials.gov Identifier: NCT00739908
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
CeNeRx BioPharma Inc.

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: CX157 (TriRima)
Drug: Placebo
Enrollment 285
Recruitment Details The study was conducted at 14 out-patient medical centers in the United States (US) from 16 September 2008 (date of first subject randomized) to 09 July 2009 (last subject’s last visit).
Pre-assignment Details A total of 587 subjects were screened. Three hundred and two (302) subjects failed to meet study entry criteria, and thus were screen failures. The top three reasons for screen failure were: IDS-SR30 total score cut-off for randomization not met (204 pts); presence of cardiovascular abnormality (18 pts) and Laboratory Abnormalities (14 pts).
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI) Placebo does not have any active medication and is the same as a Sugar Pill.
Period Title: Overall Study
Started 142 143
Completed 117 118
Not Completed 25 25
Reason Not Completed
Adverse Event             5             6
Withdrawal by Subject             4             2
Lost to Follow-up             14             9
Non-Compliance With Study Procedures             2             3
Non-Compliance With Study Medication             0             3
Lack of Efficacy             0             1
Relocation             0             1
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID Total
Hide Arm/Group Description CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI) Placebo does not have any active medication and is the same as a Sugar Pill. Total of all reporting groups
Overall Number of Baseline Participants 142 143 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
<=18 years
0
   0.0%
5
   3.5%
5
   1.8%
Between 18 and 65 years
142
 100.0%
138
  96.5%
280
  98.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 143 participants 285 participants
39.1  (11.14) 38.5  (11.16) 38.8  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
Female
80
  56.3%
81
  56.6%
161
  56.5%
Male
62
  43.7%
62
  43.4%
124
  43.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
American Indian or Alaska Native
3
   2.1%
2
   1.4%
5
   1.8%
Asian
3
   2.1%
2
   1.4%
5
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
30
  21.1%
32
  22.4%
62
  21.8%
White
102
  71.8%
105
  73.4%
207
  72.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   2.8%
2
   1.4%
6
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 142 participants 143 participants 285 participants
142 143 285
1.Primary Outcome
Title Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.
Time Frame Randomization and study end (Week 6).
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
No active medication, the same as a Sugar Pill
Overall Number of Participants Analyzed 139 143
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-12.5
(-14.4 to -10.5)
-12.3
(-14.2 to -10.3)
2.Secondary Outcome
Title Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate
Hide Description MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.
Time Frame Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomization MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.7
(24.0 to 40.1)
34.3
(26.5 to 42.7)
3.Secondary Outcome
Title Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate
Hide Description Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.
Time Frame Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
19.4
(13.2 to 27)
23.1
(16.4 to 30.9)
4.Secondary Outcome
Title The Hospital Anxiety and Depression Scale (HADS)
Hide Description HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.
Time Frame Randomization and Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.7
(-10.1 to -7.2)
-8.9
(-10.3 to -7.5)
5.Secondary Outcome
Title Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)
Hide Description IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.
Time Frame Randomization and Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-22.58
(-26.34 to -18.82)
-23.39
(-26.99 to -19.79)
6.Secondary Outcome
Title Clinical Global Impression - Improvement of Illness (CGI-I)
Hide Description The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject’s total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants "very much improved" and "much improved" at Week 6 or the last available post treatment result (LOCF) is reported here.
Time Frame Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Measure Type: Number
Unit of Measure: Percentage of Participants
36.7 39.9
7.Secondary Outcome
Title Clinical Global Impression - Severity of Illness (CGI-S)
Hide Description CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).
Time Frame Week 6 or the last available post treatment result (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population consisted of all patients with at least one post randomzation MADRS score.
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description:
CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Placebo does not have any active medication and is the same as a Sugar Pill.
Overall Number of Participants Analyzed 139 143
Measure Type: Number
Unit of Measure: Percentage of Participants
36.7 39.9
Time Frame 16 September 2008 (date of first subject randomized) to 09 July 2009 (last subject’s last visit)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Hide Arm/Group Description CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI) Placebo does not have any active medication and is the same as a Sugar Pill.
All-Cause Mortality
Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/142 (2.11%)      3/143 (2.10%)    
Infections and infestations     
Urinary Tract Infection (UTI) † 1  1/142 (0.70%)  1 0/143 (0.00%)  0
Injury, poisoning and procedural complications     
Jaw Fracture † 1  0/142 (0.00%)  0 1/143 (0.70%)  1
Skin Laceration † 1  0/142 (0.00%)  0 1/143 (0.70%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion † 1  1/142 (0.70%)  1 0/143 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation † 1  1/142 (0.70%)  1 0/143 (0.00%)  0
Suicidal Attempt † 1  0/142 (0.00%)  0 1/143 (0.70%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral CX157 60 mg TID (Total Daily Dose of 180 mg) Oral Placebo TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/142 (27.46%)      27/143 (18.88%)    
Gastrointestinal disorders     
Diarrhoea † 1  9/142 (6.34%)  9 6/143 (4.20%)  6
Dyspepsia † 1  9/142 (6.34%)  9 6/143 (4.20%)  6
Infections and infestations     
Upper Respiratory Tract Infection (URTI) † 1  8/142 (5.63%)  8 5/143 (3.50%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  7/142 (4.93%)  7 5/143 (3.50%)  5
Psychiatric disorders     
Insomnia † 1  8/142 (5.63%)  8 5/143 (3.50%)  5
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Subjects were asked to take 6 capsules 3 times a day for 6 weeks. Non-adherence with the study medication was high based on the population PK data. This likely contributed to the results in CX157 treatment group.
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.
The investigators were informed that the first publication or disclosure of study results shall be a complete, joint multicenter publication or disclosure coordinated by CeNeRx. Thereafter, any secondary publications will reference the original publication(s).
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mahnaz Asgharnejad, Pharm.D.; Daniel Burch, M.D.
Organization: CeNeRx BioPharma Inc.
Phone: (919) 655 1435; (919) 674 6041
EMail: masgharnejad@cenerx.com; danburch@cenerx.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: CeNeRx BioPharma Inc.
ClinicalTrials.gov Identifier: NCT00739908     History of Changes
Other Study ID Numbers: CX157-200
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: February 14, 2012
Results First Posted: June 27, 2012
Last Update Posted: June 27, 2012