Clinical trial

A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode

Name

P05844

Description

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Trial arms

Trial start

2005-06-02

Estimated PCD

2007-02-28

Trial end

2007-03-22

Status

Completed

Phase

Early phase I

Treatment

Asenapine

Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.

Arms:

Asenapine

Other names:

Org 5222

Placebo

Placebo fast dissolving SL tablets, BID

Arms:

Placebo

Size

326

Primary endpoint

Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21

Baseline and Day 21

Eligibility criteria

Inclusion Criteria: * Have bipolar I disorder, current episode manic or mixed * Treated with lithium or valproic acid Exclusion Criteria: * Have an unstable medical condition * Clinically significant laboratory abnormality. * Have a primary diagnosis other than bipolar I disorder.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 326, 'type': 'ACTUAL'}}

Updated at

2024-05-21

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug