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Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study (CBD-IS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cannabidiol CR
Cannabidiol
Amisulpride
Olanzapine
Quetiapine
Risperidone
Placebo
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Central Institute of Mental Health
  • Dept. of Pharmacology, University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cannabidiol

Cannabidiol CR

Amisulpride and Cannabidiol CR

Olanzapine and Cannabidiol CR

Quetiapine and Cannabidiol CR

Risperidone and Cannabidiol CR

Cannabidiol CR and Placebo

Arm Description

Cannabidiol capsule, 200 mg single dose

Cannabidiol tablet, various dosages

Interaction between Amisulpride and Cannabidiol CR

Interaction between Olanzapine and Cannabidiol CR

Interaction between Quetiapine and Cannabidiol CR

Interaction between Risperidone and Cannabidiol CR

Cannabidiol CR levels without interaction with antipsychotics

Outcomes

Primary Outcome Measures

Plasma levels of cannabidiol

Secondary Outcome Measures

Area Under Curve (AUC)
serum antipsychotic concentration

Full Information

First Posted
September 18, 2013
Last Updated
March 7, 2018
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02051387
Brief Title
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
Acronym
CBD-IS
Official Title
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Active Comparator
Arm Description
Cannabidiol capsule, 200 mg single dose
Arm Title
Cannabidiol CR
Arm Type
Experimental
Arm Description
Cannabidiol tablet, various dosages
Arm Title
Amisulpride and Cannabidiol CR
Arm Type
Experimental
Arm Description
Interaction between Amisulpride and Cannabidiol CR
Arm Title
Olanzapine and Cannabidiol CR
Arm Type
Experimental
Arm Description
Interaction between Olanzapine and Cannabidiol CR
Arm Title
Quetiapine and Cannabidiol CR
Arm Type
Experimental
Arm Description
Interaction between Quetiapine and Cannabidiol CR
Arm Title
Risperidone and Cannabidiol CR
Arm Type
Experimental
Arm Description
Interaction between Risperidone and Cannabidiol CR
Arm Title
Cannabidiol CR and Placebo
Arm Type
Placebo Comparator
Arm Description
Cannabidiol CR levels without interaction with antipsychotics
Intervention Type
Drug
Intervention Name(s)
Cannabidiol CR
Other Intervention Name(s)
Arvisol
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Plasma levels of cannabidiol
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Area Under Curve (AUC)
Time Frame
up to 10 days
Title
serum antipsychotic concentration
Time Frame
baseline and after seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
State/Province
BW
ZIP/Postal Code
68159
Country
Germany
Facility Name
Dept. of Pharmacology, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50931
Country
Germany

12. IPD Sharing Statement

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Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

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