A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode

PHASE4CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Schizophrenia
Interventions
DRUG

Oral risperidone

Oral risperidone 1 mg or 2 mg or 3 mg will be administered for 21 days from the first dose of RLAI (until RLAI injection becomes effective) and then taper off over the next 5 days. Thereafter, oral risperidone can be administered at the discretion of the Investigator if additional antipsychotic medication will be required due to acute exacerbation of symptoms between visits.

DRUG

Risperidone Long-Acting Injection (RLAI)

RLAI 25 mg to 50 mg will be administered, intramuscularly which will be tapered and discontinued over a period of up to 6 weeks.

DRUG

Risperidone Long-Acting Injection (RLAI)

Participants who will experience a disease relapse, will receive RLAI 25 mg, 37.5 mg, or 50 mg, every 2 weeks as an intramuscular injection in the gluteus for up to 24 months.

Trial Locations (1)

Unknown

Bellville

All Listed Sponsors
lead

Janssen Cilag N.V./S.A.

INDUSTRY

NCT00378092 - A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode | Biotech Hunter | Biotech Hunter