Enhancing Recovery in Early Schizophrenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02926859 |
Recruitment Status :
Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : February 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Cannabidiol as add-on Drug: Placebo as add-on | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol vs. Placebo as an add-on to an Individualized Antipsychotic Treatment |
Actual Study Start Date : | April 8, 2017 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Cannabidiol
Cannabidiol as add-on to individualized pharmacological treatment
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Drug: Cannabidiol as add-on
Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks |
Placebo Comparator: Placebo
Placebo as add-on to individualized pharmacological treatment
|
Drug: Placebo as add-on
Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks |
- All-cause discontinuation [ Time Frame: within 12 month ]
- Improvement in Psychopathology assessed by PANSS [ Time Frame: 6, 9 and 12 month ]Positive and Negative Syndrome Scale (PANSS)
- Improvement in Psychopathology assessed by CGI [ Time Frame: 6, 9 and 12 month ]Clinical Global Impression (CGI)
- Improvement in Psychopathology assessed by BSI-53 [ Time Frame: 6, 9 and 12 month ]Brief Symptom Inventory (BSI-53)
- Improvement in Psychopathology assessed by FROGS [ Time Frame: 6, 9 and 12 month ]Functional Remission of General Schizophrenia (FROGS)
- Changes from baseline in Depression Scale [ Time Frame: 6, 9 and 12 month ]Calgary Depression Scale for Schizophrenia (CDSS)
- Improvement in social and occupational functioning assessed by GAF [ Time Frame: 6, 9 and 12 month ]Global Assessment of Functioning (GAF)
- Improvement in social and occupational functioning assessed by PSP [ Time Frame: 6, 9 and 12 month ]Personal and Social Performance Scale (PSP)
- Improvement in social and occupational functioning assessed by EMA [ Time Frame: 6, 9 and 12 month ]Ecological Momentary Assessment (EMA)
- Improvement in Quality of life assessed by WHOQUOL-Bref [ Time Frame: 6, 9 and 12 month ]WHO Quality of Life-Bref (WHOQUOL-Bref)
- Improvement in Quality of life assessed by LQLP [ Time Frame: 6, 9 and 12 month ]Lancashire Quality of Life Profile (LQLP)
- Changes from baseline in Neurocognition assessed by B-CATS [ Time Frame: 6, 9 and 12 month ]Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
- Changes from baseline in Neurocognition assessed by BACS [ Time Frame: 6, 9 and 12 month ]Brief Assessment of Cognition in Schizophrenia (BACS)
- Changes from baseline in Neurocognition assessed by UPSA-B [ Time Frame: 6, 9 and 12 month ]University of California San Diego Performance based Skills Assessment (UPSA-B)
- Changes from baseline in Neurocognition assessed by MASC [ Time Frame: 6, 9 and 12 month ]Movie for the Assessment of Social Cognition (MASC)
- Changes from baseline in Neurocognition assessed by PFA [ Time Frame: 6, 9 and 12 month ]Pictures of Facial Affect (PFA)
- Treatment adherence [ Time Frame: 6, 9 and 12 month ]
- Changes in Cumulative dose of concomitant or rescue medication [ Time Frame: 6, 9 and 12 month ]
- Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling [ Time Frame: 6, 9 and 12 month ]
- Side effects: weight gain [ Time Frame: 6, 9 and 12 month ]Body Mass Index, abdominal girth
- Side effects: Vital Signs [ Time Frame: 6, 9 and 12 month ]heart rate, blood pressure, electrocardiography
- Side effects: UKU Side Effect rating scale [ Time Frame: 6, 9 and 12 month ]
- Side effects: Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 6, 9 and 12 month ]
- Side effects: Evaluation of extrapyramidal symptoms (EPS) [ Time Frame: 6, 9 and 12 month ]
- Side effects: physical and neurological examination [ Time Frame: 6, 9 and 12 month ]
- Standard blood tests [ Time Frame: 6, 9 and 12 month ]
- Columbia Suicidality Sverity Rating Scale (C-SSRS) [ Time Frame: 6, 9 and 12 month ]

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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 (295.10-30, 295.90)
- First documented diagnosis of schizophrenia must not be no older than seven years.
- Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
- Initial PANSS total score of ≤ 75 at baseline.
- proper contraception in female patients of childbearing potential
- body mass index between 18 and 40.
Exclusion Criteria:
- Lack of accountability
- positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- serious suicidal risk at screening visit
- other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
- other relevant neurological or other medical disorders
- pregnancy 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): NCT02926859
Germany | |
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, Charité, Campus Charité-Mitte | |
Berlin, B, Germany, 10117 | |
Department of Psychiatry, Psychotherapy, and Psychosomatics, RWTH Aachen | |
Aachen, NRW, Germany, 52074 | |
Dept. of Psychiatry and Psychotherapy, University Hospital of Cologne | |
Cologne, NRW, Germany, 50924 | |
Department of Psychiatry und Psychotherapy, University Hospital Hamburg-Eppendorf | |
Hamburg, Germany, 20246 |
Principal Investigator: | F. Markus Leweke, MD | Central Institute of Mental Health |
Responsible Party: | Central Institute of Mental Health, Mannheim |
ClinicalTrials.gov Identifier: | NCT02926859 |
Other Study ID Numbers: |
CBD-ESPRIT |
First Posted: | October 6, 2016 Key Record Dates |
Last Update Posted: | February 24, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Epidiolex Anticonvulsants |