The Role of the Endocannabinoid System in Psychiatric Disorders and Symptoms: a Pharmacological fMRI study - THC-phMRI in patients

• Conditions: THis research project will be performed with patients with a psychiatric disorder in order to determine whether the endocannabinoid system is altered in psychiatric diseases. Psychistric disorders that are investigated are schizophrenia, depression, ADHD, OCD and addiction. Patients will be compared with healthy controls.; MedDRA version: 9.1Level: SOCClassification code 10037175Term: Psychiatric disorders; MedDRA version: 9.1Level: LLTClassification code 10051623Term: Cannabinoids

• Registration Number: EUCTR2007-004247-30-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Diagnosed with one psychiatric disorder (according to DSM-IV)
•History of mild cannabis use for at least one year (<1/week and = 4/year)
•Right-handedness, assessed with the Edinburgh Handedness Inventory
•Written informed consent of the patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any clinical significant abnormality of any clinical laboratory test, except for the predetermined psychiatric disorder, including urinary drug screening
•Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see paragraph 8.3.1)
•Current diagnosis alcohol and/or drug abuse (DSM-IV criteria)
•Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2
•Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
•The use of any medication within three weeks prior to the start of the study, except for paracetamol and medication for the psychiatric disorder
•Claustrophobia
•Metal objects in or around the body (braces, pacemaker, metal fragments)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether and how the endocannabinoid system is involved in psychiatric disorders.;Secondary Objective: ;Primary end point(s): THe investigator can decide to withdraw a patient from the study. This can be due to medical reasons, for example when serious side effects occur, or when patients need procedures that are not allowed in the protocol. In case of repeated withdrawal of patients for urgent medical reasons, the investigator will decide to end the study prematurely.