Phobic anxiety disorders: either generalized social phobia or panic disorder with agoraphobia. MedDRA version: 18.1 Level: HLT Classification code 10068299 Term: Fear symptoms and phobic disorders (incl social phobia) System Organ Class: 100000004873
Conditions
Interventions
Product Name: Cannabidiol
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Universiteit Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that administration of cannabidiol as an augmentation step in combination with exposure therapy can strengthen treatment outcome in patients with phobic disorders (generalized social anxiety and panic disorder with agoraphobia) who do not respond satisfactorily to treatment as usual.;Secondary Objective: Goal 2: To experimentally study the fear extinction enhancing properties of cannabidiol in patients. Does cannabidiol lead to faster fear extinction than placebo in phobic individuals, when tested in a controlled laboratory fear conditioning model? Goal 3: To profile patients depending on genetic/biological/personality characteristics in order to be able to use personalised treatments for individuals. Goal 4: Examine the cost effectiveness of cannabidiol as opposed to exposure therapy alone. Goal 5: Explore epigenetic differences ;Primary end point(s): The primary outcome measure will be the fear questionnaire (FQ) which measures presence and severity of all relevant phobic symptoms (Marks and Mathews 1979).;Timepoint(s) of evaluation of this end point: Baseline, after every session, mid treatment, post treatment and at 3 and 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures: 1. General outcome measures: - Beck Anxiety Inventory (BAI; Beck and Steer 1990), on global anxiety severity; - Clinical Global Impression (CGI; Guy, 1976), on global functioning; - Beck Depression Inventory (BDI-2; Beck and Steer 1990), on depression severity; - Bodily Symptoms questionnaire Chambless et al. 1985); - Euro QOL 5D (Quality of Life; (EuroQol_group 1990), on global quality of life; - Tic-P (Hakkaart-van Roijen 2002), on loss of work and productivity due to disease. 2. Disorder specific symptom measures: - In PD+AGO the Panic Disorder Severity Scale (PDSS; Shear et al. 1997), the Mobility Inventory and the Agoraphobic Cognitions Questionnaire (MI, ACQ) - Social phobia: the Social Phobia and Anxiety Inventory (SPAI; Bogels and Reith 1999; Bogels et al. 2010) and the Liebowitz Social Anxiety Scale (Mennin et al. 2002). Weekly measures during the sessions in the study period: - Subjective Unit of Distress Scale (SUDS; Wolpe 1969) is used to measure degree of in-session habituation/ and across session extinction, measured at the beginning and end of each session. - Quality of the ERP sessions ;Timepoint(s) of evaluation of this end point: taken at baseline, weekly after the 8 study ERP sessions, at mid treatment, at post-treatment and at 3 and 6 months follow up | — |
Countries
Netherlands
Contacts
Public ContactDr. J.M.P. Baas
Utrecht University
Outcome results
None listed