SchizophreniaPhase 1CBD-ISNCT02051387
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
A Phase 1 study testing Cannabidiol CR, Cannabidiol and Amisulpride in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 2 sites in Germany.
Trial summary
Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cannabidiol CR, Cannabidiol and Amisulpride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2013to Aug 2017
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent given by the subject
- Both, female and male subjects may participate
- Age between 18 and 45
- Negative drug screening at the time of screening
- Non-smoking
- In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
- Body Mass Index between 18 and 30
Who cannot join
- Lack of accountability
- Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
- Pregnancy or lactation phase in female at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history concerning psychiatric disorders
- Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
- Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
- Consumption of any illicit drugs (except cannabis in history, see above)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept. of Pharmacology, University of Cologne
Cologne, North Rhine-Westphalia, 50931
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.
Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.
In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.
- Conditions
- Schizophrenia
- Being tested
- Cannabidiol CR, Cannabidiol, Amisulpride, Olanzapine, Quetiapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol CRDrug
Also called Arvisol
CannabidiolDrug
AmisulprideDrug
OlanzapineDrug
QuetiapineDrug
RisperidoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Active comparator | Cannabidiol capsule, 200 mg single dose Receives: Drug: Cannabidiol |
| Cannabidiol CR | Experimental | Cannabidiol tablet, various dosages Receives: Drug: Cannabidiol CR |
| Amisulpride and Cannabidiol CR | Experimental | Interaction between Amisulpride and Cannabidiol CR Receives: Drug: Cannabidiol CR; Drug: Amisulpride |
| Olanzapine and Cannabidiol CR | Experimental | Interaction between Olanzapine and Cannabidiol CR Receives: Drug: Cannabidiol CR; Drug: Olanzapine |
| Quetiapine and Cannabidiol CR | Experimental | Interaction between Quetiapine and Cannabidiol CR Receives: Drug: Cannabidiol CR; Drug: Quetiapine |
| Risperidone and Cannabidiol CR | Experimental | Interaction between Risperidone and Cannabidiol CR Receives: Drug: Cannabidiol CR; Drug: Risperidone |
| Cannabidiol CR and Placebo | Placebo comparator | Cannabidiol CR levels without interaction with antipsychotics Receives: Drug: Cannabidiol CR; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of cannabidiol
Measured: up to 10 days
Secondary outcomes (2)
Area Under Curve (AUC)
Measured: up to 10 days
serum antipsychotic concentration
Measured: baseline and after seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2017
- Study completionAug 2017
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051387
- Sponsor's protocol ID
- CBD-IS
- Other IDs
- 2008-008245-38, 2008
- Acronym
- CBD-IS
- Status last verified
- Mar 2018
- First submitted
- 18 Sep 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
- ClinicalTrials.gov ID
- NCT02051387
- Acronym / sponsor ID
- CBD-IS / CBD-IS
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- University of Cologne
- Study start
- Jan 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 31 Jan 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.
Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.
Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.
In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Active comparator | Drug: CannabidiolCannabidiol capsule, 200 mg single dose |
| Cannabidiol CR | Experimental | Drug: Cannabidiol CRCannabidiol tablet, various dosages |
| Amisulpride and Cannabidiol CR | Experimental | Drug: Cannabidiol CR, Drug: AmisulprideInteraction between Amisulpride and Cannabidiol CR |
| Olanzapine and Cannabidiol CR | Experimental | Drug: Cannabidiol CR, Drug: OlanzapineInteraction between Olanzapine and Cannabidiol CR |
| Quetiapine and Cannabidiol CR | Experimental | Drug: Cannabidiol CR, Drug: QuetiapineInteraction between Quetiapine and Cannabidiol CR |
| Risperidone and Cannabidiol CR | Experimental | Drug: Cannabidiol CR, Drug: RisperidoneInteraction between Risperidone and Cannabidiol CR |
| Cannabidiol CR and Placebo | Placebo comparator | Drug: Cannabidiol CR, Drug: PlaceboCannabidiol CR levels without interaction with antipsychotics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent given by the subject
- Both, female and male subjects may participate
- Age between 18 and 45
- Negative drug screening at the time of screening
- Non-smoking
Key exclusion criteria (8 listed)
- Lack of accountability
- Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
- Pregnancy or lactation phase in female at the time of screening
- Any known psychiatric or neurological illness in the participant's history.
- Known family history concerning psychiatric disorders
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 |
|---|---|---|
| Cannabidiol CRAlso: Arvisol | Drug | Amisulpride and Cannabidiol CR, Cannabidiol CR, Cannabidiol CR and Placebo, Olanzapine and Cannabidiol CR, Quetiapine and Cannabidiol CR, Risperidone and Cannabidiol CR |
| Cannabidiol | Drug | Cannabidiol |
| Amisulpride | Drug | Amisulpride and Cannabidiol CR |
| Olanzapine | Drug | Olanzapine and Cannabidiol CR |
| Quetiapine | Drug | Quetiapine and Cannabidiol CR |
| Risperidone | Drug | Risperidone and Cannabidiol CR |
| Placebo | Drug | Cannabidiol CR and Placebo |
Primary outcome
Plasma levels of cannabidiol
Time frame: up to 10 days
2 secondary outcomes
Area Under Curve (AUC)
Time frame: up to 10 days
serum antipsychotic concentration
Time frame: baseline and after seven days
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 8 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol CR, Cannabidiol and Amisulpride in people with Schizophrenia, run by Central Institute of Mental Health, Mannheim at 2 sites 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 7 inclusion and 8 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 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Plasma levels of cannabidiol (time frame: up to 10 days). 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 8 Mar 2018.