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Enhancing Recovery in Early Schizophrenia

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Jun 2026 to Dec 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v14
  2. Primary completion date: Dec 2024 to Jun 2026
    • Study completion date: Dec 2025 to Jun 2026
    • Site contacts updated at 6 of 6 sites
    v13
  3. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2025
    v12
  4. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Mar 2023 to Dec 2023
    • Study completion date: Mar 2023 to Dec 2024
    • Site details revised at 6 of 6 sites
    v11
  5. Primary and study completion dates: Jan 2021 to Mar 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 5 to 6
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Mar 2020 to Jan 2021v9
  2. Primary and study completion dates: Mar 2019 to Mar 2020v8
  3. Primary and study completion dates: Dec 2018 to Mar 2019v7
  4. Study sites revised (5)v6
  5. Eligibility criteria shortened, about 5 wordsv5
  6. Start date changed from estimate of Apr 2017 to Apr 8, 2017v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2016 to Apr 2017
    • Site details revised at 5 of 5 sites
    v3
  8. Secondary endpoints revised (18)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.
Trial Details
NCT Number NCT02926859
Lead Sponsor Central Institute of Mental Health, Mannheim
Conditions
(from sponsor)		 Schizophrenia
Related terms Schizophrenia
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov