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: 9.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders MedDRA version: 9.1 Level: LLT Classification code 10051623 Term: Cannabinoids
Conditions
Interventions
Product Name: Dronabinol
Pharmaceutical Form: Inhalation vapour, liquid
Pharmaceutical form of the placebo: Inhalation vapour, liquid
Route of administration of the placebo: Inhalation use
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Diagnosed with one psychiatric disorder (according to DSM-IV) •History of mild cannabis use for at least one year (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.) 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed