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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)

This study has been completed.
Sponsor:
Collaborator:
BrainCells Inc.
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00705003
First received: June 23, 2008
Last updated: June 17, 2014
Last verified: June 2014
Results First Received: March 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 9 study centers between April and December 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BCI-024 and BCI-049 (Buspirone and Melatonin) 1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
BCI-024 (Buspirone) 1 over-encapsulated tablet of buspirone 15 mg QD
Placebo Matching placebo QD

Participant Flow for 2 periods

Period 1:   Enrolled
    BCI-024 and BCI-049 (Buspirone and Melatonin)   BCI-024 (Buspirone)   Placebo
STARTED   71   37   34 
COMPLETED   67   34   33 
NOT COMPLETED   4   3   1 

Period 2:   Treated
    BCI-024 and BCI-049 (Buspirone and Melatonin)   BCI-024 (Buspirone)   Placebo
STARTED   67   34   33 
COMPLETED   54   28   30 
NOT COMPLETED   13   6   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BCI-024 and BCI-049 Buspirone 15 mg and Melatonin 3 mg QD
BCI-024 Buspirone 15 mg QD
Placebo Placebo QD
Total Total of all reporting groups

Baseline Measures
   BCI-024 and BCI-049   BCI-024   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   34   33   134 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   67   34   33   134 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.1  (12.06)   40.8  (12.55)   42.7  (11.62)   42.4  (12.03) 
Gender 
[Units: Participants]
       
Female   43   20   24   87 
Male   24   14   9   47 
Region of Enrollment 
[Units: Participants]
       
United States   67   34   33   134 


  Outcome Measures
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1.  Primary:   The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6   [ Time Frame: Week 6 ]

2.  Secondary:   The Change From Baseline in the CGI-S at Week 6   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   The Change From Baseline in the IDS-C30 at Week 6   [ Time Frame: Week 0 and Week 6 ]

4.  Secondary:   The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   The Change From Baseline on the HAM-A at Week 6   [ Time Frame: Week 0 and Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: mfava@partners.org



Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00705003     History of Changes
Other Study ID Numbers: CBM-IT-01
Study First Received: June 23, 2008
Results First Received: March 12, 2013
Last Updated: June 17, 2014