CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Combination Product: BCI-024 + BCI-049drug
Likely dose
Not stated in 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/NCT00731653
NCT00731653Phase 2Completed
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An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder

Massachusetts General Hospital·interventional·Posted Aug 11, 2008·Updated Dec 17, 2013

In Brief

A Phase 2 clinical trial evaluating Combination Product: BCI-024 + BCI-049 for Major Depressive Disorder. Completed, enrolled 81 participants across 9 sites.

Detailed Summary

The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049. The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.9 years ago

Interventions

Combination Product: BCI-024 + BCI-049drug

BCI-024 and BCI-049 once a day at bedtime for 6 weeks