Does adding cannabidiol (a component of cannabis) enhance the treatment of phobias where patients are confronted with their fears (exposure treatment).
- Conditions
- Phobic anxiety disorders: either generalized social phobia or panic disorder with agoraphobia.MedDRA version: 18.1Level: HLTClassification code 10068299Term: Fear symptoms and phobic disorders (incl social phobia)System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-004094-17-NL
- Lead Sponsor
- niversiteit Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients will be invited to participate when they fulfill the DSM IV criteria for a diagnosis of either generalized social phobia or panic disorder with agoraphobia, and provided that they have not or only partially responded to treatment in the year preceding referral to the outpatient clinics. We will use the following definition of patients who only partially responded to treatment:
a) having been treated in the past year for the same symptoms (psycho- or pharmacotherapy) and/or
b) specifically referred to second-line treatment to Altrecht or GGZ inGeest
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 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients with co-morbid severe psychiatric disorders (severe major depressive or bipolar disorder, psychosis, dependence of alcohol and drugs), with mental deficiency (IQ<80) or inability to adequately read or speak Dutch will be excluded, as well as persons with (a history of) epilepsy, cardiovascular disease or brain damage, renal or liver abnormalities, and a history of allergies on medication (adverse reactions or rash).
Regular use of benzodiazepines and of antipsychotics will be an exclusion criterion, since benzodiazepine use might hamper the ERP effect. Use of SSRIs will be permitted, provided that dosages are kept constant during the study.
Lastly pregnant or breastfeeding women will be excluded from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method