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

NCT01029769 | Completed Results DMC

• 1 other identifier: 01KG0910
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders

  Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is \>3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating

  8 weeks

Secondary Outcomes (1)

• PANSS Total Score Change

  8 weeks

Study Arms (5)

initial olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine or amisulpride

initial amisulpride

ACTIVE COMPARATOR

Drug: Olanzapine or amisulpride

early responders

ACTIVE COMPARATOR

Drug: Olanzapine or amisulpride

early non-responders switched

ACTIVE COMPARATOR

Drug: Olanzapine or amisulpride

ealy non-responders non-switched

ACTIVE COMPARATOR

Drug: Olanzapine or amisulpride

Interventions

Olanzapine or amisulpride DRUG

Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding

ealy non-responders non-switched; early non-responders switched; early responders; initial amisulpride; initial olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• contraindication to study drugs

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine; Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Patients with poor response to antipsychotic treatment in the past (treatment resistant patients) were not excluded by definition from study participation.

Results Point of Contact

• Title: Prof. Dr. Dr. Stefan Leucht
• Organization: Technische Universitaet Muenchen, Germany

stefan.leucht@tum.de

+498941404200

Study Officials

• Stefan Leucht, MD

  Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universität München am Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2015-05

Locations

DE (1)