A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

NCT00665366 Phase 3 COMPLETED Results posted

The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

Details

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	493
Start date	2008-06
Completion	2011-10

Conditions

• Bipolar Disorder Mania

Interventions

• Aripiprazole
• Placebo
• Lithium
• Valproate

Primary outcomes

• Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set) — Baseline to Week 12
  The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.

Countries

Austria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Turkey (Türkiye)