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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Combination Product: BCI-024 + BCI-049

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00731653

CBM-IT-01-EXT

Details and patient eligibility

About

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.

Full description

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

81 participants in 1 patient group

1

Experimental group

Description:

BCI-024 and BCI-049

Treatment:

Drug: Combination Product: BCI-024 + BCI-049