SchizophreniaPhase 2NCT00309413
A Clinical Trial on the Antipsychotic Properties of Cannabidiol
A Phase 2 study of Schizophrenia and Psychotic Disorders, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Jul 2008
- 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
- DSM-IV Diagnosis of schizophrenic or schizophreniform psychosis
- Minimal initial score of 36 in the BPRS total score and a minimum of 12 in the BPRS Psychosis Cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content)
- Exclusion of pregnancy in female subjects through negative β-HCG test
Who cannot join
- Lack of accountability
- Pregnancy or risk of pregnancy or lactation.
- Other relevant interferences of axis 1 according to diagnostic evaluation through MINI including undifferentiated residual forms of schizophrenia.
- Treatment with depot-antipsychotics during the last three months.
- Severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. Positive Hepatitis-serology.
- QTc-elongation.
- Acute suicidal tendency of or hazard to others by the patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Cologne, Dept. of Psychiatry and Psychotherapy
Cologne, North Rhine-Westphalia, 50924
About this study
Official title: A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol
The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.
Read the detailed description
Despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. The endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures.
The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Placebo/Cannabidiol, Cannabidiol/Placebo
- Keywords
- Schizophrenia and Disorders with Psychotic Features
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo/CannabidiolDrug
600 mg/day, oral, capsules, 2 weeks, than cross-over
Cannabidiol/PlaceboDrug
600 mg/day, oral, capsules, 2 weeks, than cross-over
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cannabidiol/Placebo Receives: Drug: Cannabidiol/Placebo |
| 2 | Placebo comparator | Placebo/Cannabidiol Receives: Drug: Placebo/Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPRS
Measured: 2 x 2 weeks
Secondary outcomes (1)
PANSS, EPS, Prolactin, ECG etc.
Measured: 2 x 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionJul 2008
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Coordinating Centre for Clinical Trials Cologne
- Investigators
- F. Markus Leweke, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309413
- Sponsor's protocol ID
- CBD-PT 04-153
- Status last verified
- Jul 2008
- First submitted
- 30 Mar 2006
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Randomized Cross-Over Clinical Trial on the Antipsychotic Properties of the Endocannabinoid Modulator Cannabidiol
- ClinicalTrials.gov ID
- NCT00309413
- Acronym / sponsor ID
- CBD-PT 04-153
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Schizophrenia and Disorders with Psychotic Features
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Coordinating Centre for Clinical Trials Cologne
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 31 Mar 2006 (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.
The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.
Detailed description
Despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. The endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures.
The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Cannabidiol/PlaceboCannabidiol/Placebo |
| 2 | Placebo comparator | Drug: Placebo/CannabidiolPlacebo/Cannabidiol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV Diagnosis of schizophrenic or schizophreniform psychosis
- Minimal initial score of 36 in the BPRS total score and a minimum of 12 in the BPRS Psychosis Cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content)
- Exclusion of pregnancy in female subjects through negative β-HCG test
Key exclusion criteria (7 listed)
- Lack of accountability
- Pregnancy or risk of pregnancy or lactation.
- Other relevant interferences of axis 1 according to diagnostic evaluation through MINI including undifferentiated residual forms of schizophrenia.
- Treatment with depot-antipsychotics during the last three months.
- Severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. Positive Hepatitis-serology.
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 |
|---|---|---|
| Placebo/Cannabidiol600 mg/day, oral, capsules, 2 weeks, than cross-over | Drug | 2 |
| Cannabidiol/Placebo600 mg/day, oral, capsules, 2 weeks, than cross-over | Drug | 1 |
Primary outcome
BPRS
Time frame: 2 x 2 weeks
1 secondary outcome
PANSS, EPS, Prolactin, ECG etc.
Time frame: 2 x 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2008.
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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
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Schizophrenia and Psychotic Disorders, run by University of Cologne at 1 site in Germany.
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 3 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: finished, as of the sponsor's last update on 25 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BPRS (time frame: 2 x 2 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 25 Jul 2008.