Nordic Longterm OCD treatment Study: A Nordic Multicenter treatment study evaluating a stepped care model based on the "Expert Clinical Guidelines". The study is performed with no sponsor from pharmaceutical firms.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Zoloft or generic Sertralin preparations Product Name: Sertraline Pharmaceutical Form: Tablet INN or Proposed INN: SERTRALINE CAS Number: 79617962 CONDITION: 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 PRIMARY OUTCOME: 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. ; 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. 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). 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
Epistemonikos ID: 907be3e6cc0239354d4559aee5d708ae3df5ff62
First added on: Jul 27, 2021