Preventing Morbidity in First Episode Schizophrenia, Part II

NCT00320671 Phase 4 COMPLETED Results posted

This 52 week long study evaluates the effectiveness of aripiprazole versus risperidone in treating people with first-episode schizophrenia. Patients who do not improve with these medications receive clozapine as their third medication trial.

Details

Lead sponsor	Northwell Health
Phase	Phase 4
Status	COMPLETED
Enrolment	198
Start date	2005-12
Completion	2015-12

Conditions

• Schizophrenia

Interventions

• Aripiprazole
• Risperidone

Primary outcomes

• Percentage of Participants That Responded to Treatment — this outcome was assessed throughout the study.
  Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28

Countries

United States