NCT00309413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 25, 2008

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

March 30, 2006

Last Update Submit

July 23, 2008

Conditions

SchizophreniaPsychotic Disorders

Keywords

Schizophrenia and Disorders with Psychotic Features

Outcome Measures

Primary Outcomes (1)

  • BPRS

    2 x 2 weeks

Secondary Outcomes (1)

  • PANSS, EPS, Prolactin, ECG etc.

    2 x 2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Cannabidiol/Placebo

Drug: Cannabidiol/Placebo

2

PLACEBO COMPARATOR

Placebo/Cannabidiol

Drug: Placebo/Cannabidiol

Interventions

Placebo/CannabidiolDRUG

600 mg/day, oral, capsules, 2 weeks, than cross-over

2
Cannabidiol/PlaceboDRUG

600 mg/day, oral, capsules, 2 weeks, than cross-over

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne, Dept. of Psychiatry and Psychotherapy

Cologne, North Rhine-Westphalia, 50924, Germany

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • F. Markus Leweke, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

July 1, 2008

Last Updated

July 25, 2008

Record last verified: 2008-07

Locations

DE(1)