CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD +2 moredrug
Likely dose
BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00705003
NCT00705003Phase 2Completed
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A Double-Blind, Placebo-Controlled Study of a Combination Product (BCI-024 and BCI-049) in Patients With Major Depressive Disorder (MDD)

Massachusetts General Hospital·interventional·Posted Jun 25, 2008·Updated Jun 18, 2014

In Brief

A Phase 2 clinical trial evaluating BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD, BCI-024 (Buspirone), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 142 participants across 9 sites.

Detailed Summary

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder. The safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsBrainCells Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.0 years ago

Interventions

BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QDdrug

BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks

BCI-024 (Buspirone)drug

Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks.

Matching placebodrug

Placebo comparator once a day at bedtime for 6 weeks.