N/A N=327 Randomized Triple-blind Treatment

Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia

Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01029769 ↗

Enrolled (actual)

327

Serious AEs

3.6%

Results posted

Oct 2024

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Olanzapine or amisulpride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Technical University of Munich
Primary completion: Mar 2014

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	—

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

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

View full record on ClinicalTrials.gov →

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.