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)