N/A
Completed N=327
Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
Schizophrenia · schizoaffective disorder · Schizophreniform Disorder
Source: ClinicalTrials.gov NCT01029769 ↗
Enrolled (actual)
327
Serious AEs
3.6%
Results posted
Oct 2024
Primary outcomePrimary: Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders — 41; 25 Participants — p==0.01
Summary
The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders |
41; 25 | =0.01 sig |
| SECONDARY PANSS Total Score Change |
-22.8; -17.3 | — |
Eligibility Criteria
Inclusion Criteria
- Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV TR) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
- PANSS total score at baseline > 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)
- Increase in the level of care (outpatient care to day clinic or inpatient care)
Exclusion Criteria
- contraindication to study drugs
Data sourced from ClinicalTrials.gov (NCT01029769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.