Overview

Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy

Status:
Completed
Trial end date:
2019-04-01
Target enrollment:
0
Participant gender:
All
Summary
A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Treatments:
Amisulpride
Olanzapine
Sulpiride
Sultopride
Criteria
Inclusion Criteria:

- Patients with schizophrenia and schizoaffective disorder according to International
Classification of Diseases (ICD-10);

- age 18-65;

- Positive and Negative Symptom Scale Total-Score ≥ 70 and two items of the positive
symptom subscale ≥4.

- voluntary treatment after written informed consent

- legal capacity

- exclusion of pregnancy by laboratory test (Beta HCG)

Exclusion Criteria:

- participation in other interventional studies with drugs or medical devices

- first episode patients

- physical disease that might have effects on the conduct or evaluation of the trial

- contraindications to medication according to experts information

- oversensitivity to active substance or other component of the drugs used

- known clozapine resistance

- suicidal ideation

- pregnancy or lactation

- which of pregnancy or absence save contraception

- dependency to sponsor or investigator

- institutionalization through judicial or regulatory order

- oversensitivity to placebo (mannite/aerosil)