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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
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.
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Synergy Research Centers
San Diego, California, United States
Atlanta Institute of Medicine & Research, Inc.
Altanta, Georgia, United States
Capital Clinical Research Associates
Rockville, Maryland, United States
NorthCoast Clinical Trials
Beachwood, Ohio, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States
Start Date
July 1, 2008
Primary Completion Date
December 1, 2008
Completion Date
January 1, 2009
Last Updated
December 17, 2013
81
ACTUAL participants
Combination Product: BCI-024 + BCI-049
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07115329
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07025720