Obsessive Compulsive Disorder MedDRA version: 9.1 Level: LLT Classification code 10049596 Term: Obsession MedDRA version: 9.1 Level: LLT Classification code 10010219 Term: Compulsions
Conditions
Interventions
Trade Name: Zoloft or generic Sertralin preparations
Product Name: Sertraline
Pharmaceutical Form: Tablet
INN or Proposed INN: SERTRALINE
CAS Number: 79617962
Sponsors
The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (R.BUP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Obsessive Compulsive Disorder according to DSM IV of moderate-severe type in patients aged 7-17. Severity as defined by Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Scores of 16 or above. All patients included in step 2, involving Sertralin have failed an adequate trial of CBT for 14 sessions (in step 1), i.e. that CY-BOCS scores are still 16 or above.All co-morbidities are allowed except as defined below. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patient has been treated with CBT or Sertraline in the last year for OCD. Other psychiatric disorder with higher treatment priority (e.g. acute psychosis, suicidality in major depression, severe Anorexia nervosa). Mental retardation, Autism and Asperger's syndrome. Patient and/or parent does not understand or can speak the language. Comorbidity with ADHD, bipolar disorder etc are allowed if the patient is stabilised on the appropriate drug for at least 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find best treatment for children and adolescents with OCD who are partial- or non-responders to Cognitive Behavioural Therapy (CBT). CBT (14 session) is the treatment of choice in pediatric OCD. About a third of the patients are non- or partial responders. Non- or partial responders to CBT are randomised (Step 2) to either continued CBT or to Sertraline (with continued CBT support) to find an optimal treatment strategy: an increased "dose" of CBT or medication with Sertraline together with CBT-support. No study has studied SSRI effectiveness in CBT non- or partial responders. ;Secondary Objective: To identify predictors, moderators and mediators of good and non- or partial Sertraline- respectively CBT response in non- or partial pediatric OCD CBT responders (step2). ;Primary end point(s): CYBOCS scores at 8 weeks and 3 months after inclusion in step 2 respectively step 3. Responder is defined as the patient having reduced their CYBOCS scores to 11-15 points. Excellent response is defined as CY-BOCS scores of 10 or below. Responders will be followed up for up to 36 months (at +6, +12, +24 and +36 months) using the CY-BOCS and the stability of the treatment gains can thus be established. The Clinical Global Impression (CGI) and Clinical global Improvement (CGIimp) will be used at the same timepoints. | — |
Countries
Sweden
Outcome results
None listed