SchizophreniaPhase 2NCT02088060
A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients
A Phase 2 study testing Cannabidiol and Olanzapine in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 6 sites in 2 countries.
Trial summary
Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics are only partially effective, and their use is often associated with serious side effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cannabidiol and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 8 Dec 2015to 16 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Dept. of Psychiatry and Psychotherapy, Martin-Luther-University, Halle/Wittenberg
Halle, Saxony-Anhalt, 06112
Department of General Psychiatry, Heidelberg University
Heidelberg, Baden-Wurttemberg, 68115
Dep. of Psychiatry and Psychotherapy, Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
Dept. of Psychiatry and Psychotherapy, Ludwig-Maximillians-University Munich
Munich, Bavaria, 80336
Dept. of Psychiatry and Psychotherapy, Technical University Munich
Munich, Bavaria, 81675
About this study
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
Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics 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. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.
- Conditions
- Schizophrenia
- Being tested
- Cannabidiol, Olanzapine, Placebo Cannabidiol, Placebo Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Cannabidiol capsules
OlanzapineDrug
Also called Olanzapine 1A pharma
Olanzapine capsules
Placebo CannabidiolDrug
Placebo cannabidiol capsules
Placebo OlanzapineDrug
Placebo olanzapine capsules
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks Receives: Drug: Cannabidiol; Drug: Placebo Olanzapine |
| Olanzapine | Active comparator | Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks Receives: Drug: Olanzapine; Drug: Placebo Cannabidiol |
| Placebo | Placebo comparator | Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks Receives: Drug: Placebo Cannabidiol; Drug: Placebo Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Positive and Negative Syndrome Scale (PANSS) total score
Measured: within 4 weeks
Secondary outcomes (12)
Changes in the PANSS subscores and clusters
Measured: within 4 weeks
Changes in the Clinical Global Impression score
Measured: within 4 weeks
Changes in the Global Assessment of Functioning Scale
Measured: within 4 weeks
Changes in the Personal and Social Performance Scale
Measured: within 4 weeks
Changes in the Calgary Depression Scale for Schizophrenia
Measured: within 4 weeks
Changes in the Hamilton Anxiety Scale
Measured: within 4 weeks
Changes in cognitive skills
Measured: within 4 weeks
Response to antipsychotic medication
Measured: within 4 weeks
Plasma levels of endogenous cannabinoids
Measured: within 4 weeks
Changes in physiological parameter
Measured: within 4 weeks
Changes in the UKU Side Effect Rating Scale
Measured: within 4 weeks
Columbia Suicidality Severity Rating Scale
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study start8 Dec 2015
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Why it stopped: Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, Technical University of Munich, Ludwig-Maximilians - University of Munich, Glostrup University Hospital, Copenhagen
- Responsible party
- Sponsor
- Investigators
- F. Markus Leweke, MD, Principal investigator, Central Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088060
- Sponsor's protocol ID
- CBD-FEP
- Other IDs
- 2012-004335-23
- Status last verified
- Dec 2024
- First submitted
- 12 Mar 2014
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02088060
- Acronym / sponsor ID
- CBD-FEP
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, Technical University of Munich, Ludwig-Maximilians - University of Munich, Glostrup University Hospital, Copenhagen
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics 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. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Cannabidiol, Drug: Placebo OlanzapineCannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks |
| Olanzapine | Active comparator | Drug: Olanzapine, Drug: Placebo CannabidiolOlanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo Cannabidiol, Drug: Placebo OlanzapinePlacebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolCannabidiol capsules | Drug | Cannabidiol |
| OlanzapineAlso: Olanzapine 1A pharmaOlanzapine capsules | Drug | Olanzapine |
| Placebo CannabidiolPlacebo cannabidiol capsules | Drug | Olanzapine, Placebo |
| Placebo OlanzapinePlacebo olanzapine capsules | Drug | Cannabidiol, Placebo |
Primary outcome
Change in the Positive and Negative Syndrome Scale (PANSS) total score
Time frame: within 4 weeks
12 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Markus Leweke, MD principal investigator
Central Institute of Mental Health
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol and Olanzapine in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Positive and Negative Syndrome Scale (PANSS) total score (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.