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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01029769
Other study ID # 01KG0910
Secondary ID
Status Completed
Phase N/A
First received December 9, 2009
Last updated May 22, 2015
Start date December 2009
Est. completion date March 2015

Study information

Verified date May 2015
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial 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


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:

1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)

2. 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


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Germany Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar Munic Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients in remission at week 8 comparing the "switched" with the "non switched" early non-responders) 8 weeks No
Secondary PANSS total score change 8 weeks No
Secondary Cost of care 8 weeks No
Secondary Safety: Simpson-Angus Scale, Barnes Akathisia Scale, open interviews 8 weeks Yes
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