Phase 2
Completed N=81
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT00731653 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. — 81 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. |
81 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00731653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.