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. 2017 Jun 28;2017(6):CD009005. doi: 10.1002/14651858.CD009005.pub2

Schmidt‐Kraepelin 2013.

Trial name or title Is an antipsychotic combination treatment of olanzapine and amisulpiride more effective than monotherapy.
Methods Allocation: randomised.
 Blindness: double‐blind.
Participants Diagnosis: schizophrenia or schizoaffective disorder.
 Expected sample size: 399.
 Age: 18‐65 years.
 History: no details.
Interventions
  1. Combination therapy: olanzapine and amisulpiride.

  2. Monotherapy: olanzapine.

  3. Monotherapy: amisulpiride.

Outcomes
  1. Symptomatic improvement of schizophrenia in comparison to time of inclusion of patient measured by PANSS.

  2. Serious adverse drug reactions.

  3. Change of clinical condition measured by CGI scale.

  4. Change of the subjective well‐being measured by SWN scale.

Starting date June 2012.
Contact information Joachim Cordes (joachim.cordes@lvr.de).
Sandra Feyerabend (sandra.feyerabend@lvr.de).
Notes ClinicalTrials.gov identifier: NCT01609153.
DRKS‐ID: DRKS00003603.
Sponsor: Heinrich‐Heine University, Duesseldor.

BPRS ‐ Brief Psychiatric Rating Scale
 BMI ‐ Body Mass Index
 CGI ‐ Clinical Global Impression
 CDSS ‐ Calgary Depression Scale for Schizophrenia
 ICD ‐ International Classification of Diseases
 PANSS ‐ Positive and Negative Syndrome Scale
 SAS ‐ Simpson Angus Scale
 SOFAS ‐ Social and Occupational Functioning Assessment Scale
 SWN ‐ Subjective Well Being under Neuroleptics