Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia

NCT01810380 Phase 3 COMPLETED Results posted

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Details

Lead sponsor	H. Lundbeck A/S
Phase	Phase 3
Status	COMPLETED
Enrolment	468
Start date	2013-03
Completion	2014-12

Conditions

• Schizophrenia

Interventions

• Placebo
• Brexpiprazole
• Quetiapine extended release

Primary outcomes

• Change From Baseline to Week 6 in PANSS Total Score — Baseline and Week 6
  The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.

Countries

United States