Enhancing recovery in early schizophrenia – a multi-center, two-arm, double-blind, randomized clinical trial investigating cannabidiol vs. placebo as an add-on to an individualized antipsychotic treatment

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00011151
• Date of registration: 07/10/2016
• Prospective Registration: Yes
• Primary sponsor: Zentralinstitut für Seelische Gesundheit
• Public title: Enhancing recovery in early schizophrenia – a multi-center, two-arm, double-blind, randomized clinical trial investigating cannabidiol vs. placebo as an add-on to an individualized antipsychotic treatment
• Scientific title: Enhancing recovery in early schizophrenia – a multi-center, two-arm, double-blind, randomized clinical trial investigating cannabidiol vs. placebo as an add-on to an individualized antipsychotic treatment
• Date of first enrolment: 20/09/2017
• Target sample size: 180
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00011151
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: treatment
• Phase: 2

Countries of recruitment

Germany

Contacts

• Name: F. Markus Leweke
• Affiliation: Zentralinstitut für Seelische Gesundheit

• Name: F. Markus Leweke
• Affiliation: Zentralinstitut für Seelische Gesundheit

Key inclusion & exclusion criteria

Inclusion criteria: • Informed consent given by the subject
• DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
• First documented diagnosis of schizophrenia must not be no older than seven years
• Patients must receive a stable dose of amisulpride (50 to 1200 mg/day), aripiprazole (10 to 30 mg/day), olanzapine (5 to 20 mg/day), quetiapine (300 to 750 mg/day), or risperidone (1 to 10 mg/day) (TAU: treatment as usual) at least four 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.
Exclusion criteria: • Lack of accountability (assessed by an independent psychiatrist)
• Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines).
• Serious suicidal risk at screening visit (Subject to investigator’s judgement).
• Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
• Other relevant neurological or other medical disorders.
• Pregnancy, determined through a ß-HCG pregnancy test, or lactation

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

F20

Intervention(s)

Group 1: Cannabidiol capsules 2x200 mg p.o. twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
Group 2: Placebo capsules 2x200 mg p.o. twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks

Primary Outcome(s)

All-cause discontinuation within 12 month

Secondary Outcome(s)

• Improvement in Psychopathology from baseline over time (particularly month 6) (PANSS, CGI, BSI-53, FROGS), social and occupational functioning (GAF, PSP, EMA) and quality of life (WHOQUOL-Bref, LQLP).

• Changes from baseline over time (particularly month 6) in the Calgary Depression Scale for Schizophrenia (CDSS).

• Changes from baseline over time (particularly month 6) in Neurocogniton (B-CATS, BACS, UPSA-B, MASC and PFA).

• Treatment adherence.

• Changes of cumulative dose of concomitant or rescue medication.

• Changes of biomarkers

• Side effects (UKU, AIMS, EPS, C-SSRS, BMI, ECG, prolactin) compared to baseline over time (particularly month 6) .

• Detailed laboratory assessments.

Secondary ID(s)

2014-003215-11

NCT02926859

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Bonn

Ethics review

Status: Approved
Approval date: 02/06/2016
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00011151#studyResults