Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

June 30, 2008

Conditions
Treatment-resistant Schizophrenia
Interventions
DRUG

Amisulpride add-on

At the beginning of the treatment phase (day 1), subjects in the combination treatment group will be started with adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. All of the add-on amisulpride will be provided to subjects at night. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.

DRUG

Placebo add-on

For subjects randomly allocated to the placebo treatment group, they will be added with one capsule of placebo from Day 1. On Day 8, Day 15 and Day 22, the placebo will be increased to 2, 3 and 4 capsules, respectively. and adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.

Trial Locations (2)

Unknown

Bali Psychiatric Center, Taipei County

Departments of Psychiatry, Tao-yuan Psychiatric Center, Taoyuan District

All Listed Sponsors
lead

National Health Research Institutes, Taiwan

OTHER

NCT01105481 - Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients | Biotech Hunter | Biotech Hunter