Major Depressive DisorderPhase 2NCT00731653

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

A Phase 2 study testing Combination Product: BCI-024 + BCI-049 in people with Major Depressive Disorder, run by Massachusetts General Hospital at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Combination Product: BCI-024 + BCI-049
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 9 sitesUnited States
Study dates: Jul 2008to Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.

Who cannot join

Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Atlanta Institute of Medicine & Research, Inc.
Altanta, Georgia, 30328
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78756
NorthCoast Clinical Trials
Beachwood, Ohio, 44122
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, 77008
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Capital Clinical Research Associates
Rockville, Maryland, 20852
Synergy Research Centers
San Diego, California, 91950

Other trials in United States

About this study

Official title: An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder

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.

Read the detailed description

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Conditions: Major Depressive Disorder
Being tested: Combination Product: BCI-024 + BCI-049
Keywords: depression, combination
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination Product: BCI-024 + BCI-049Drug
BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Study groups in NCT00731653
Study group	Role	What they receive
1	Experimental	BCI-024 and BCI-049 Receives: Drug: Combination Product: BCI-024 + BCI-049

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
Measured: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jan 2009

First posted11 Aug 2008 (estimated)
Study startJul 2008
Primary completionDec 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00731653
Sponsor's protocol ID: CBM-IT-01-EXT
Status last verified: Oct 2013
First submitted: 7 Aug 2008
Last updated: 17 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00731653
Acronym / sponsor ID: CBM-IT-01-EXT
Conditions: Major Depressive Disorder
Keywords: depression, combination
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: BrainCells Inc.
Study start: Jul 2008
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 17 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Combination Product: BCI-024 + BCI-049BCI-024 and BCI-049

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.

Key exclusion criteria (1 listed)

Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combination Product: BCI-024 + BCI-049BCI-024 and BCI-049 once a day at bedtime for 6 weeks	Drug	1

Primary outcome

The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
Time frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Results and safety

Results posted to the registry on 17 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BCI-024 and BCI-049 (Buspirone and Melatonin)	81	72

Primary outcome: The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.

Time frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment). Number. Unit: participants

Measure	BCI-024 and BCI-049 (Buspirone and Melatonin) n = 81
Value	81

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCI-024 and BCI-049 (Buspirone and Melatonin)	0 of 81 (0%)	42 of 81 (51.9%)	Not reported

Limitations and caveats (from the sponsor): This was an open-label study. Conclusions regarding the efficacy of the combination study drug were not made.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maurizio Fava, MD principal investigator

Massachusetts General Hospital

Andrew A Nierenberg, MD principal investigator

Massachusetts General Hospital

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combination Product: BCI-024 + BCI-049 in people with Major Depressive Disorder, run by Massachusetts General Hospital at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. (time frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.