A Clinical Trial on the Antipsychotic Properties of Canna... | NCT00309413

Studies
A Clinical Trial on the Antipsychotic Properties of Cannabidiol

NCT00309413

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Jul 25, 2008Estimated

Enrollment

29Actual

Phase

Phase 2

Conditions

Schizophrenia
Psychotic Disorders

Interventions

Placebo/Cannabidiol
Cannabidiol/Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Mar 30, 2006

First Submission Date that Met QC Criteria

Mar 30, 2006

First Posted Date

Mar 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2008

Last Update Posted Date

Jul 25, 2008Estimated

Name	Class
Stanley Medical Research Institute	OTHER
Coordinating Centre for Clinical Trials Cologne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Cannabidiol/Placebo	Drug: Cannabidiol/Placebo
2	Placebo Comparator	Placebo/Cannabidiol	Drug: Placebo/Cannabidiol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo/Cannabidiol	Drug	600 mg/day, oral, capsules, 2 weeks, than cross-over	2

Measure	Description	Time Frame
BPRS		2 x 2 weeks

Measure	Description	Time Frame
PANSS, EPS, Prolactin, ECG etc.		2 x 2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
F. Markus Leweke, MD	University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne, Dept. of Psychiatry and Psychotherapy		Cologne	North Rhine-Westphalia	50924	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D019967	Schizophrenia Spectrum and Other Psychotic Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002185	Cannabidiol

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided