Trial Outcomes & Findings for Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD) (NCT NCT00731653)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Results posted on

2013-12-17

Participant Flow

Following their participation in the CBM-IT-01 study, subjects were offered the opportunity to participate in this open-label extension study. The study was conducted 9 study centers between June 2008 and February 2009.

Participant milestones

Participant milestones
Measure	BCI-024 and BCI-049 (Buspirone and Melatonin) BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Overall Study STARTED	81
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCI-024 and BCI-049 (Buspirone and Melatonin) n=81 Participants BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	43.7 years STANDARD_DEVIATION 11.59 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Population: All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.

Outcome measures

Outcome measures
Measure	BCI-024 and BCI-049 (Buspirone and Melatonin) n=81 Participants BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.	81 participants

Adverse Events

BCI-024 and BCI-049 (Buspirone and Melatonin)

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BCI-024 and BCI-049 (Buspirone and Melatonin) n=81 participants at risk BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Nervous system disorders Headache	16.0% 13/81 • Number of events 14
Nervous system disorders Somnolence	7.4% 6/81 • Number of events 6
Nervous system disorders Dizziness	6.2% 5/81 • Number of events 5
Gastrointestinal disorders Diarrhea	8.6% 7/81 • Number of events 7
Gastrointestinal disorders Dry Mouth	7.4% 6/81 • Number of events 6
Gastrointestinal disorders Nausea	6.2% 5/81 • Number of events 5

Additional Information

Maurizio Fava, MD

Massachusetts General Hospital

Phone: 617-724-2513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place