Asenapine for Bipolar Depression

Status Terminated

Clinical Trial Summary

The purpose of this study is to compare asenapine with placebo in the treatment of depression associated with bipolar disorder, type I over eight weeks.

We hypothesize that patients will show significantly greater improvement with asenapine than placebo over eight weeks of treatment.

Clinical Trial Description

86 patients with an episode of major depression associated with bipolar disorder, type I will be recruited by two sites for the study over fifteen months. Medication will be administered in a double-blind manner. Patients will receive asenapine (or placebo) beginning on day 0 at 5 mg bid. Dose may be increased to 10 mg bid and adjusted based on clinical response. Patients will be evaluated by a blinded (to treatment status) rater. Patients will be seen and ratings obtained at baseline (day 0) and on days 7, 14, 28, 42, and 56 (or termination from the study). Adverse events will be evaluated as well. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01807741
Study type	Interventional
Source	University of Cincinnati
Contact
Status	Terminated
Phase	Phase 2
Start date	September 2013
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03256162` - Ketamine as an Adjunctive Therapy for Major Depression	Phase 1
Recruiting	`NCT03396744` - Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression	Phase 1/Phase 2
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Completed	`NCT02363738` - 12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression	Phase 2
Recruiting	`NCT01213121` - Neurophysiologic Changes in Patients With Bipolar Depression	Phase 4
Completed	`NCT01919892` - Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium	Phase 4
Completed	`NCT00762268` - A Trial of SAMe for Treatment-Resistant Bipolar Depression	N/A
Terminated	`NCT00566111` - Ceftriaxone in the Management of Bipolar Depression	N/A
Terminated	`NCT00217217` - Low Field Magnetic Stimulation Treatment for Bipolar Depression	Phase 3
Recruiting	`NCT04998773` - Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression	N/A
Recruiting	`NCT04939649` - Ketamine as an Adjunctive Therapy for Major Depression (2)	Phase 3
Completed	`NCT03658824` - Behavioural Activation for Bipolar Depression: A Case Series	N/A
Suspended	`NCT03674671` - Ketamine Versus Electroconvulsive Therapy in Depression	Phase 3
Recruiting	`NCT05340686` - Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression	N/A
Recruiting	`NCT05296356` - OSU6162 in Bipolar Depression (OBID)	Phase 2
Recruiting	`NCT03711019` - Efficacy of Convulsive Therapies During Continuation	N/A
Completed	`NCT02088580` - Feasibility and Tolerability of Adjunct Chronotherapy in Depressed Inpatients	N/A
Terminated	`NCT00272025` - Treatment Resistant Bipolar Depression	Phase 1
Completed	`NCT00566150` - Levetiracetam in the Management of Bipolar Depression	N/A