A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol as a Treatment for Acutely Ill Schizophrenic Patients
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ClinicalTrials.gov Identifier: NCT02088060 |
Recruitment Status :
Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : April 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Cannabidiol Drug: Olanzapine Drug: Placebo Cannabidiol Drug: Placebo Olanzapine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Four-week, Multicentre, Double-blinded, Randomised, Active- and Placebo- Controlled, Parallel-group Trial Investigating Efficacy and Safety of Cannabidiol in Acute, Early-stage Schizophrenic Patients |
Study Start Date : | March 2014 |
Estimated Primary Completion Date : | May 2022 |
Estimated Study Completion Date : | August 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Cannabidiol
Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks
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Drug: Cannabidiol
Cannabidiol capsules Drug: Placebo Olanzapine Placebo olanzapine capsules |
Active Comparator: Olanzapine
Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks
|
Drug: Olanzapine
Olanzapine capsules
Other Name: Olanzapine 1A pharma Drug: Placebo Cannabidiol Placebo cannabidiol capsules |
Placebo Comparator: Placebo
Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks
|
Drug: Placebo Cannabidiol
Placebo cannabidiol capsules Drug: Placebo Olanzapine Placebo olanzapine capsules |
- Change in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: within 4 weeks ]
- Changes in the PANSS subscores and clusters [ Time Frame: within 4 weeks ]
- Changes in the Clinical Global Impression score [ Time Frame: within 4 weeks ]
- Changes in the Global Assessment of Functioning Scale [ Time Frame: within 4 weeks ]
- Changes in the Personal and Social Performance Scale [ Time Frame: within 4 weeks ]
- Changes in the Calgary Depression Scale for Schizophrenia [ Time Frame: within 4 weeks ]
- Changes in the Hamilton Anxiety Scale [ Time Frame: within 4 weeks ]
- Changes in cognitive skills [ Time Frame: within 4 weeks ]
- Response to antipsychotic medication [ Time Frame: within 4 weeks ]
- Plasma levels of endogenous cannabinoids [ Time Frame: within 4 weeks ]
- Changes in physiological parameter [ Time Frame: within 4 weeks ]
- Changes in the UKU Side Effect Rating Scale [ Time Frame: within 4 weeks ]
- Columbia Suicidality Severity Rating Scale [ Time Frame: within 4 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent given by the subject
- DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90 (American Psychiatric Association)
- Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
- Age 18 to 65 years, male or female
- Minimal initial PANSS score of 75 at baseline
- Female patients of childbearing potential need to utilize a proper method of contraception.
- Body Mass Index between 18 and 40
Exclusion Criteria:
- Lack of accountability (assessed by an independent psychiatrist)
- History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
- Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)
- Known intolerance or allergy to olanzapine or cannabidiol
- Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia
- Pregnancy, as determined through a β-HCG pregnancy test, or lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088060
Denmark | |
Psychiatric Centre Glostrup | |
Glostrup, Denmark, 2600 | |
Germany | |
Department of General Psychiatry, Heidelberg University | |
Heidelberg, BW, Germany, 68115 | |
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health | |
Mannheim, BW, Germany, 68159 | |
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich | |
Munich, BY, Germany, 80336 | |
Dept. of Psychiatry and Psychotherapy, Technical University Munich | |
Munich, BY, Germany, 81675 | |
Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg | |
Halle, Saint, Germany, 06112 |
Principal Investigator: | F. Markus Leweke, MD | Central Institute of Mental Health |
Responsible Party: | Central Institute of Mental Health, Mannheim |
ClinicalTrials.gov Identifier: | NCT02088060 |
Other Study ID Numbers: |
CBD-FEP 2012-004335-23 ( EudraCT Number ) |
First Posted: | March 14, 2014 Key Record Dates |
Last Update Posted: | April 27, 2021 |
Last Verified: | April 2021 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Cannabidiol Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Anticonvulsants |