Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Schizophrenia
Interventions
DRUG

Aripiprazole and aripiprazole once-monthly

Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

DRUG

Paliperidone and paliperidone palmitate

Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Trial Locations (2)

90660

US002, Los Angeles

92102

US006, San Diego

Sponsors
All Listed Sponsors
collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

lead

H. Lundbeck A/S

INDUSTRY