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Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT00705003
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Collaborator:
BrainCells Inc.
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

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: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD
Drug: BCI-024 (Buspirone)
Drug: Matching placebo
Enrollment 142
Recruitment Details Patients were recruited at 9 study centers between April and December 2008
Pre-assignment Details  
Arm/Group Title BCI-024 and BCI-049 (Buspirone and Melatonin) BCI-024 (Buspirone) Placebo
Hide Arm/Group Description 1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD 1 over-encapsulated tablet of buspirone 15 mg QD Matching placebo QD
Period Title: Enrolled
Started 71 37 34
Completed 67 34 33
Not Completed 4 3 1
Period Title: Treated
Started 67 34 33
Completed 54 28 30
Not Completed 13 6 3
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo Total
Hide Arm/Group Description Buspirone 15 mg and Melatonin 3 mg QD Buspirone 15 mg QD Placebo QD Total of all reporting groups
Overall Number of Baseline Participants 67 34 33 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 34 participants 33 participants 134 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
67
 100.0%
34
 100.0%
33
 100.0%
134
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 34 participants 33 participants 134 participants
43.1  (12.06) 40.8  (12.55) 42.7  (11.62) 42.4  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 34 participants 33 participants 134 participants
Female
43
  64.2%
20
  58.8%
24
  72.7%
87
  64.9%
Male
24
  35.8%
14
  41.2%
9
  27.3%
47
  35.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants 34 participants 33 participants 134 participants
67 34 33 134
1.Primary Outcome
Title The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6
Hide Description

Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)

The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to “Rate the patient’s total improvement whether or not, in your judgment, it is due entirely to drug treatment.” The Investigator was asked “Compared to the patient’s condition at the Baseline visit, please assign a rating to how much the patient changed.” Responses for the CGI-I evaluation included the following categories:

0: Not Assessed

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.
Arm/Group Title BCI-024+BCI-049 BCI-024 Placebo
Hide Arm/Group Description:
Buspirone 15 mg and Melatonin 3 mg QD
Buspirone 15 mg QD
Placebo QD
Overall Number of Participants Analyzed 67 34 33
Mean (Standard Error)
Unit of Measure: units on a scale
2.37  (0.97) 2.82  (1.24) 2.86  (1.09)
2.Secondary Outcome
Title The Change From Baseline in the CGI-S at Week 6
Hide Description

Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: “Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.”

Possible responses include the following:

0: Not Assessed

  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. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo
Hide Arm/Group Description:
Buspirone 15 mg and Melatonin 3 mg QD
Buspirone 15 mg QD
Placebo QD
Overall Number of Participants Analyzed 67 34 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.43  (1.08) .93  (1.07) 0.97  (1.16)
3.Secondary Outcome
Title The Change From Baseline in the IDS-C30 at Week 6
Hide Description The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.
Time Frame Week 0 and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo
Hide Arm/Group Description:
Buspirone 15 mg and Melatonin 3 mg QD
Buspirone 15 mg QD
Placebo QD
Overall Number of Participants Analyzed 67 34 33
Mean (Standard Error)
Unit of Measure: units on a scale
19.24  (1.60) 16.35  (2.22) 14.42  (2.14)
4.Secondary Outcome
Title The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6
Hide Description

The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:

  1. highest score from items 1-4 (Sleep Items)
  2. item 5 score
  3. highest score from items 6-9 (appetite/weight)
  4. item 10 score
  5. item 11 score
  6. item 12 score
  7. item 13 score
  8. item 14 score
  9. highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo
Hide Arm/Group Description:
Buspirone 15 mg and Melatonin 3 mg QD
Buspirone 15 mg QD
Placebo QD
Overall Number of Participants Analyzed 67 34 33
Mean (Standard Error)
Unit of Measure: units on a scale
8.57  (0.66) 6.65  (0.92) 7.31  (0.89)
5.Secondary Outcome
Title The Change From Baseline on the HAM-A at Week 6
Hide Description

The 14-item HAM-A scale rates the patient’s level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer’s assessment of the patient’s appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).

The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement.

Time Frame Week 0 and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo
Hide Arm/Group Description:
Buspirone 15 mg and Melatonin 3 mg QD
Buspirone 15 mg QD
Placebo QD
Overall Number of Participants Analyzed 67 34 33
Mean (Standard Error)
Unit of Measure: units on a scale
9.04  (0.87) 6.69  (1.20) 6.51  (1.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BCI-024 and BCI-049 BCI-024 Placebo
Hide Arm/Group Description Buspirone 15 mg and Melatonin 3 mg QD Buspirone 15 mg QD Placebo QD
All-Cause Mortality
BCI-024 and BCI-049 BCI-024 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BCI-024 and BCI-049 BCI-024 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/34 (0.00%)      0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BCI-024 and BCI-049 BCI-024 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/67 (23.88%)      7/34 (20.59%)      4/33 (12.12%)    
Gastrointestinal disorders       
Diarrhea  1  6/67 (8.96%)  6 1/34 (2.94%)  1 2/33 (6.06%)  2
Constipation  1  1/67 (1.49%)  1 2/34 (5.88%)  2 0/33 (0.00%)  0
Nervous system disorders       
Dizziness  1  4/67 (5.97%)  4 1/34 (2.94%)  1 0/33 (0.00%)  0
Headache  1  5/67 (7.46%)  5 3/34 (8.82%)  3 2/33 (6.06%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Maurizio Fava, MD
Organization: Massachusetts General Hospital
Phone: 617-724-2513
Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00705003     History of Changes
Other Study ID Numbers: CBM-IT-01
First Submitted: June 23, 2008
First Posted: June 25, 2008
Results First Submitted: March 12, 2013
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014