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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Olanzapine or amisulpride

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inpatients with 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

initial olanzapin

initial amisulpride

early responders

early non-responders switched

ealy non-responders non-switched

Arm Description

Outcomes

Primary Outcome Measures

Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders)

Secondary Outcome Measures

PANSS total score change

Cost of care

Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews

Full Information

NCT ID

NCT01029769

First Posted

December 9, 2009

Last Updated

May 22, 2015

Sponsor

Technical University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT01029769

Brief Title

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

Official Title

The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technical University of Munich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day. Those participants who have not responded to treatment at two weeks (PANSS improvement <25%) will be randomised to a 6 week double blind flexible dose phase: Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d) Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

351 (Actual)

8. Arms, Groups, and Interventions

Arm Title

initial olanzapin

Arm Type

Active Comparator

Arm Title

initial amisulpride

Arm Type

Active Comparator

Arm Title

early responders

Arm Type

Active Comparator

Arm Title

early non-responders switched

Arm Type

Active Comparator

Arm Title

ealy non-responders non-switched

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Olanzapine or amisulpride

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

PANSS total score change

Time Frame

8 weeks

Title

Cost of care

Time Frame

8 weeks

Title

Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inpatients with 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Leucht, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Munic

State/Province

Bavaria

ZIP/Postal Code

81675

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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