Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study
| ISRCTN | ISRCTN66385119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66385119 |
| Secondary identifying numbers | NordLOTS protocol 1.2 |
- Submission date
- 20/10/2007
- Registration date
- 19/03/2008
- Last edited
- 10/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Pediatric Obsessive Compulsive Disorder (OCD) is a serious and often chronic disorder involving obsessive and excessive fears, and behaviours ( i.e., rituals) that aim to neutralize the fears and dangers. The symptoms lead to impairment and reduced quality of life. There is impressive evidence for the effectiveness of Cognitive Behaviour Therapy (CBT) with exposure to the feared situations and response prevention of the rituals. Moreover, CBT gives good symptom relief in many, better than drug treatments (i.e., serotonin reuptake inhibiting drugs [SSRIs]). SSRI treatment also has an impressive evidence base. However, little is known about what treatments to offer in children and adolescents who do not benefit from CBT. So, our study aims at investigating whether continued CBT or a switch to sertraline (an SSRI) is best in these non-responding children and adolescents. However, we are also interested in investigating whether regular child and adolescent clinicians can be taught such CBT and be as efficient as psychotherapists working in specialized OCD clinics.
Who can participate?
Children and adolescents, aged 7-17 years, with moderate to severe OCD.
What does the study involve?
Following a thorough baseline diagnostic work-up, patients participate in 14 sessions of CBT. Assessments are made also at the 7th and 13th weeks of the therapy. Youngsters who do not benefit from CBT are then randomly allocated to either sertraline or to continued CBT.
What are the possible benefits and risks of participating?
The participants receive state-of-the-art CBT and drug treatment which increase the chance of symptom relief, while the risks are small.
Where is the study run from?
Three Scandinavian countries (Sweden, Norway and Denmark) contribute. The Center for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP) is the data center.
When is the study starting and how long is it expected to run for?
The study started in 2008, has now stopped inclusion, and is currently working on a long-term follow-up scheme to study whether gains from therapy are durable.
Who is funding the study?
All participating centers finance their own contribution with the aid of the local hospital or grants from research foundations. At RBUP, grants from research foundations have covered costs associated with graduate students. RBUP and the Norwegian Research Council have contributed to an electronic data capture system.
Who is the main contact?
Dr Tord Ivarsson
tord.ivarsson@r-bup.no
Contact information
Scientific
Gullhaug Torg 4B
Oslo
0484
Norway
| Phone | +47 (0)22 58 60 00 |
|---|---|
| tord.ivarsson@r-bup.no |
Study information
| Study design | Randomized active controlled trial with three steps: 1: Open uncontrolled 2: Randomised and controlled 3: Open uncontrolled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study |
| Study acronym | NordLOTS |
| Study objectives | 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 sertraline responders is possible. Non responders to CBT and sertraline will benefit from aripiprazol augmentation. |
| Ethics approval(s) | 1. Denmark, Institutional Review Board (IRB) (Den videnskabsetiske komité for Region Midtjylland), ref: 20070140 2. Sweden, IRB, 04/02/2008 3. Norway, IRB, 10/03/2008 |
| Health condition(s) or problem(s) studied | Obsessive compulsive disorder |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sertraline, aripiprazole |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/01/2008 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 300 in step 1; 100 in step 2; 30 in step 3 |
| Total final enrolment | 269 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Denmark
- Norway
- Sweden
Study participating centre
0484
Norway
Sponsor information
Research organisation
Gullhaug Torg 4B
Oslo
0484
Norway
| Phone | +47 (0)22 58 60 00 |
|---|---|
| tord.ivarsson@r-bup.no | |
| Website | http://www.r-bup.no/ |
"ROR" |
https://ror.org/042s03372 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/10/2014 | Yes | No | ||
| Results article | 01/03/2015 | Yes | No | ||
| Results article | 01/11/2019 | 21/04/2020 | Yes | No | |
| Results article | 01/04/2021 | 19/04/2021 | Yes | No | |
| Results article | Quality of life results | 01/04/2021 | 22/04/2021 | Yes | No |
| Results article | Relapse rates following remission | 03/12/2023 | 11/12/2023 | Yes | No |
| Results article | 09/07/2025 | 10/07/2025 | Yes | No |
Editorial Notes
10/07/2025: Publication reference added.
11/12/2023: Publication reference added.
22/04/2021: Publication reference added.
19/04/2021: Publication reference added.
21/04/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
20/10/2016: Publication reference added.
Updated 21/02/2014:
31/10/2012: the last patient in the step 1 of the study was treated and post-treatment assessment was performed.
31/03/2013: the last patient in the step 2 of the study was treated and post-treatment assessment was performed.
01/04/2013: the study entered the long-term follow-up stage, which is expected to continue until 31/12/2016.
