Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Bipolar DisorderBipolar Depression
Interventions
DRUG

citalopram + mood stabilizer

Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.

DRUG

placebo + mood stabilizer

This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.

Trial Locations (1)

27705

Duke University, Durham

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Tufts Medical Center

OTHER

NCT00562861 - Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram | Biotech Hunter | Biotech Hunter