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Completed

NCT Number: NCT01609153

Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RWTH Aachen, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olanzapine

Drug

Coated tablet 5-20 mg milligram(s) per day for 16 weeks

Other names: Zyprexa

Amisulpride

Drug

200-800 mg milligram(s)per day for 16 weeks

Other names: Amisulprid Hexal

Olanzapine and Amisulpride

Drug

Zyprexa:

Coated tablet 5-20 mg milligram(s) per day for 16 weeks

Amisulpride:

Coated tablet 200-800 mg milligram(s)per day for 16 weeks

Other names: Zyprexa, Amisuprid Hexal

Primary outcomes

  1. Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)

    Time frame: 8 weeks

    Whether there is a symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)

Secondary outcomes

  1. Symptomatic improvement of schizophrenia after 16 weeks of treatment in comparison to time of inclusion of patient measured py PANSS total score reduction

    Time frame: 16 weeks.

    To study whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to week 16.

  2. Symptomatic improvement of schizophrenia from baseline to week 2 up to week 16 measured by PANSS total score reduction.

    Time frame: Every 2 weeks up to week 16.

    Whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to every 2 weeks up to week 16.

  3. PANSS total score reduction from baseline to week 2 as a predictor of the change after 8 weeks

    Time frame: 8 weeks

    Whether a change of PANSS total score reduction from baseline to week 2 is a predictor of the change after 8 weeks

  4. Serious adverse drug reactions

    Time frame: 16 weeks

    Frequency and severity of serious adverse drug reactions

  5. Change of clinical condition measured by Clinical Global Impression Scale (CGI scale)

    Time frame: every 2 weeks from baseline up to week 16

    Whether there is a change of clinical condition measured by Clinical Global Impression Scale (CGI scale)

  6. Change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale (SWN-K)

    Time frame: between week 0, 8, 16

    Whether there is a change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale(SWN-K)

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

A Randomized Double-blind Controlled Trial to Assess the Benefits of Olanzapine and Amisulpride Combination Treatment in Acutely Ill Schizophrenia Patients. - COMBINE

Acronym: COMBINE

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 31, 2012
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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