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

April 15, 2019 updated by: Heinrich-Heine University, Duesseldorf

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • RWTH Aachen
      • Alzey, Germany, 55232
        • Rheinhessen Fachklinik Alzey
      • Andernach, Germany, 56626
        • Rhein-Mosel-Fachklinik Andernach
      • Augsburg, Germany, 89156
        • Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg
      • Berlin, Germany, 10117
        • Charite-Universitatsmedizin Berlin
      • Dortmund, Germany, 44281
        • LWL-Klinik Dortmund
      • Düsseldorf, Germany, 40629
        • LVR-Klinikum Düsseldorf
      • Groß-Umstadt, Germany, 64823
        • Zentrum für Seelische Gesundheit Kreiskliniken Darmstadt-Dieburg Standort: Groß-Umstadt
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen
      • Günzburg, Germany, 89312
        • Klinik für Psychiatrie, Psychotherapie und Psychosomatik am Bezirkskrankehaus Günzburg
      • Hannover, Germany, 30625
        • Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie Medizinische Hochschule Hannover (MHH)
      • Heidelberg, Germany, 69115
        • Universitätsklinikum Heidelberg
      • Köln, Germany, 51109
        • LVR-Klinikum Köln
      • Langenfeld, Germany, 40764
        • LVR-Klinik Langenfeld
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz Klinik für Psychiatrie und Psychotherapie
      • Mannheim, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit
      • München, Germany, 80336
        • LMU München
      • München, Germany, 81675
        • TU München
      • Regensburg, Germany, 93053
        • Bezirksklinikum Regensburg, Klinik für Psychiatrie und Psychotherapie
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Olanzapine or Placebo
Drug: Amisulpride
200-800 mg milligram(s)per day for 16 weeks
Other Names:
  • Amisulprid Hexal
Drug: Olanzapine and Amisulpride

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
Active Comparator: Amisulpride or Placebo
Drug: Olanzapine and Amisulpride

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
Drug: Olanzapine
Coated tablet 5-20 mg milligram(s) per day for 16 weeks
Other Names:
  • Zyprexa
Active Comparator: Olanzapine and Amisulpride
Drug: Amisulpride
200-800 mg milligram(s)per day for 16 weeks
Other Names:
  • Amisulprid Hexal
Drug: Olanzapine
Coated tablet 5-20 mg milligram(s) per day for 16 weeks
Other Names:
  • Zyprexa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks.
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.
Every 2 weeks up to week 16.
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
8 weeks
Serious adverse drug reactions
Time Frame: 16 weeks
Frequency and severity of serious adverse drug reactions
16 weeks
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)
every 2 weeks from baseline up to week 16
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)
between week 0, 8, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Schmidt-Kraepelin, Dr., Heinrich-Heine University, Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COMBINE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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