Response was measured during 33 weeks of treatment.
Patients who relapsed following randomization to placebo were offered entry into an open-label extension phase.
The post relapse treatment phase was 52 weeks.
Fourteen of 97 patients (14.4%) who had initially responded favorably to treatment were nonresponsive to treatment following relapse.
Among these 14, the mean change in PANSS scores following 32 weeks of medication was −18.2 prior to relapse and +7 following relapse.
Relapse was defined as:
- Hospitalization for symptoms of schizophrenia.
- ≥25% increase in PANSS total score for 2 consecutive assessments if PANSS total was >40 at randomization, or ≥10-point PANSS total score increase for those with ≤40 at randomization.
- Deliberate self-harm, significant aggression; suicidality or homicidality.
- Increase in individual PANSS items.
- P1, P2, P3, P6, P7, and G8 to ≥5 for those whose score was ≤3 at randomization, or to ≥6 if score was 4 at randomization.
Nonresponse was defined as failure to achieve a 20% improvement in PANSS after at least 8 weeks of treatment.
Reference:
Emsley R, Nuamah I, Hough D, Gopal S. Treatment response after relapse in a placebo-controlled maintenance trial in schizophrenia. Schizophr Res. 2012; 138(1) :29-34.