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02 September 2010
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| [ Print-friendly version ] |
| Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study |
| ISRCTN | ISRCTN66385119 |
| ClinicalTrials.gov identifier | |
| Public title | Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study |
| Scientific title | |
| Acronym | NordLOTS |
| Serial number at source | NordLOTS protocol 1.2 |
| Study hypothesis | Children and adolescents with obsessive compulsive disorder (OCD) who do not respond to a course of cognitive behaviour therapy (CBT) will benefit equally from sertraline and from continued CBT. Identification of CBT versus sertralin responders is possible. Non responders to CBT and sertraline will benefit from aripiprazol augmentation. |
| Ethics approval |
Ethics approval received from:
1. Denmark, Institutional Review Board (IRB) (Den videnskabsetiske komité for Region Midtjylland) (ref: 20070140) 2. Sweden, IRB, approved on 04/02/2008 3. Norway, IRB, approved on 10/03/2008 |
| Study design |
Randomised, active controlled trial with three steps:
1: Open uncontrolled 2: Randomised and controlled 3: Open uncontrolled |
| Countries of recruitment | Denmark, Norway, Sweden |
| Disease/condition/study domain | Obsessive compulsive disorder |
| Participants - inclusion criteria |
1. Patients 7 - 17 years of age
2. Moderate-severe obsessive compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV). Severity is defined by Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) scores of 16 or above. |
| Participants - exclusion criteria |
1. Co-morbidity has not higher treatment priority (e.g. psychosis, anorexia nervosa, severe depression with suicidality, an autistic disorder or Asperger’s syndrome)
2. Pervasive developmental disorders (PDD) not otherwise specified (NOS) is allowed if Clinical Global Impression (CGI) score for the PDD is less than or equal to 3 and CGI for the PDD NOS is less than or equal to CGI for the OCD 3. Mental retardation (intelligence quotient [IQ] less than 70) 4. Patients have not been treated with selective serotonin reuptake inhibitor (SSRI) or CBT for their OCD during the last year 5. If the patient is of non-Nordic ethnicity both the patient and one parent must speak a Nordic language |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 300 in step 1; 100 in step 2; 30 in step 3 |
| Interventions |
Step 1: Cognitive behaviour therapy (CBT)
Step 2: Sertraline plus CBT support (less intensive CBT) or intensive CBT Step 3: Sertraline plus CBT support plus aripiprazol Non-responders to CBT are randomised to continued CBT or sertraline with CBT support. CBT plus sertraline non-responders are treated un-controlled with aripiprazol. Outcome is studied for 36 months. Dosing schedule of sertraline: Week 0: no dose given Week 1: 25 mg for 3 days, then 50 mg (range: 25 - 50 mg) Week 2: 75 mg (range: 50 - 75 mg) Weeks 3 - 4: 100 mg (range: 75 - 100 mg) Weeks 5 - 7: 150 mg (range: 75 - 150 mg) Weeks 8 - 12: 200 mg (range: 75 - 200 mg) Weeks 6 - 12: 200 mg (range: 75 - 200 mg) Dosing schedule of aripiprazol: Week 0: no dose given Week 1: 2.5 mg for 7 days (range: 2.5 mg) Weeks 2 - 4: 5 mg (range: 2.5 - 5 mg) Weeks 5 - 7: 7.5 mg (range: 2.5 - 7.5 mg) Weeks 8 - 12: 10 - 20 mg (range: 2.5 - 20 mg) Weeks 12 onwards: 2.5 - 20 mg |
| Primary outcome measure(s) |
1. CYBOCS
2. Clinical Global Impression Scale 3. Clinical Global Improvement Scale 4. Children's OCD Impact Scale Outcomes measured (approximately) at weeks 0, 7, 13, and months 6, 12, 24, 36. |
| Secondary outcome measure(s) |
1. Screen for Child Anxiety Related Disorders Revised (SCARED-R)
2. Mood and Feelings Questionnaire (MFQ) 3. Children's Global Assessment Scale (CGAS) 4. Child Behaviour Checklist (CBCL) 5. Family Accomodation Scale (FAS) 6. Need to add another treatment Outcomes measured (approximately) at weeks 0, 7, 13, and months 6, 12, 24, 36. |
| Sources of funding |
1. The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (Regionsenter for Barn og Unges Psykiske helse [R.BUP]) (Norway) - for the Nordic coordination
2. The participating clinics finance their participation from local funding agencies |
| Trial website | |
| Publications | |
| Contact name | Dr Tord Ivarsson |
| Address | Gullhaug Torg 4B |
| City/town | Oslo |
| Zip/Postcode | 0484 |
| Country | Norway |
| Tel | +47 22 58 60 00 |
| Fax | +47 22 58 60 01 |
| tord.ivarsson@r-bup.no | |
| Sponsor | The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (R.BUP) (Norway) |
| Address | Gullhaug Torg 4B |
| City/town | Oslo |
| Zip/Postcode | 0484 |
| Country | Norway |
| Tel | +47 22 58 60 00 |
| Fax | +47 22 58 60 01 |
| tord.ivarsson@r-bup.no | |
| Sponsor website: | http://www.r-bup.no/ |
| Date applied | 20/10/2007 |
| Last edited | 11/08/2008 |
| Date ISRCTN assigned | 19/03/2008 |
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| © 2010 ISRCTN unless otherwise stated. | |
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