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Enhancing recovery in early schizophrenia: A study comparing cannabidiol and placebo as add-on to standard antipsychotic treatment.
EU CTIS ID: 2024-517198-26-00
What this study is testing
To evaluate the efficacy of cannabidiol compared to placebo as an add-on to state-of-the-art antipsychotic maintenance treatment of schizophrenia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent given by the subject
- DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
- DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
- Patients must receive a stable oral dose of amisulpride (up to 1200 mg/day), aripiprazole (up to 30 mg/day), olanzapine (up to 20 mg/day), paliperidone (up to 12 mg/day), quetiapine (up to 750 mg/day), or risperidone (up to 10 mg/day) (TAU: treatment as usual) at least two weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received
- Age 18 to 65 years, male or female
- Initial PANSS total score of ≤ 75 at baseline
You likely can't join if
- Lack of accountability (assessed by an independent psychiatrist)
- Treatment-resistant schizophrenia (TRS) defined as the persistence of symptoms despite ≥2 trials of antipsychotic medications of adequate dose and duration with documented adherence
- Use of long-acting antipsychotics <3 months of end of proposed duration of action of respective dosage form prior to randomization
- Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- Serious suicidal risk at screening visit (Subject to investigator’s judgment)
- Other relevant interferences of axis 1 (e.g., serious depression) according to diagnostic evaluation (M.I.N.I) including residual forms of schizophrenia
See the full eligibility criteria
- Informed consent given by the subject
- DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
- DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
- Patients must receive a stable oral dose of amisulpride (up to 1200 mg/day), aripiprazole (up to 30 mg/day), olanzapine (up to 20 mg/day), paliperidone (up to 12 mg/day), quetiapine (up to 750 mg/day), or risperidone (up to 10 mg/day) (TAU: treatment as usual) at least two weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received
- Age 18 to 65 years, male or female
- Initial PANSS total 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 (Subjects with a BMI>40 and no further medical conditions that could indicate a metabolic syn-drome may enter the study based on the approval of the coordinating investigator)
- Fluent in German or English
- Lack of accountability (assessed by an independent psychiatrist)
- Treatment-resistant schizophrenia (TRS) defined as the persistence of symptoms despite ≥2 trials of antipsychotic medications of adequate dose and duration with documented adherence
- Use of long-acting antipsychotics <3 months of end of proposed duration of action of respective dosage form prior to randomization
- Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- Serious suicidal risk at screening visit (Subject to investigator’s judgment)
- Other relevant interferences of axis 1 (e.g., serious depression) according to diagnostic evaluation (M.I.N.I) including residual forms of schizophrenia
- Other relevant neurological or other medical disorders
- Pregnancy, determined through a β-HCG pregnancy test, or nursing (i.e., lactation at screening visit)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.