Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy (COMBINE)

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Amisulpride; Drug: Olanzapine; Drug: Olanzapine and Amisulpride

Study type: Interventional

Funder types: Other

Identifiers

NCT01609153

COMBINE

Details and patient eligibility

About

A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.

Full description

Polypharmacy in antipsychotic therapy is an important issue when treating patients with schizophrenia. It is not well confirmed that a combination of two antipsychotic drugs lead to therapeutic benefit in contrast to monotherapy. However there is a highly frequent practice of combining atypical non-clozapine treatment that could be due to potential benefits when seeking alternatives to a high rate of non-response in acute phase. Therefore there is a need for further trials of sufficient power to address efficacy and safety issues of this regimen. Combining two selected atypical drugs in a complementary way may minimize side-effects and enhance efficacy. In order to specify these advantages it is intend to examine approaches to combination treatment: Amisulpride and olanzapine show complementing receptor binding profiles and have shown to have efficacy and good tolerability when administered in combination in retrospective studies. The object of this trial is to study whether acutely ill patients with combination of amisulpride and olanzapine are more frequently in symptomatic remission after 8 weeks than those with olanzapine or amisulpride monotherapy.

Enrollment: 328 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 3 patient groups

Olanzapine or Placebo

Active Comparator group

Treatment:

Drug: Olanzapine and Amisulpride

Drug: Amisulpride

Amisulpride or Placebo

Active Comparator group

Treatment:

Drug: Olanzapine and Amisulpride

Drug: Olanzapine

Olanzapine and Amisulpride

Active Comparator group

Treatment:

Drug: Olanzapine

Drug: Amisulpride