Condition category
Mental and Behavioural Disorders
Date applied
20/10/2007
Date assigned
19/03/2008
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 re-uptake inhibiting drugs (SSRI)). 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 (a 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, 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 7th and 13th week 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 (Sweden, Norway and Denmark) countries 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 has covered costs associated with graduate students. RBUP and the Norwegian Research Council has contributed to an electronic data capture system.

Who is the main contact?
Dr Tord Ivarsson
tord.ivarsson@r-bup.no

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tord Ivarsson

ORCID ID

Contact details

Gullhaug Torg 4B
Oslo
0484
Norway
+47 (0)22 58 60 00
tord.ivarsson@r-bup.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NordLOTS protocol 1.2

Study information

Scientific title

Nordic Long-term Obsessive compulsive disorder (OCD) Treatment Study

Acronym

NordLOTS

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 sertraline responders is possible. Non responders to CBT and sertraline will benefit from aripiprazol augmentation.

Ethics approval

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

Study design

Randomised, 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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

Sertraline, aripiprazol

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300 in step 1; 100 in step 2; 30 in step 3

Participant 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

Recruitment start date

01/01/2008

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Denmark, Norway, Sweden

Trial participating centre

Gullhaug Torg 4B
Oslo
0484
Norway

Sponsor information

Organisation

The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (R.BUP) (Norway)

Sponsor details

Gullhaug Torg 4B
Oslo
0484
Norway
+47 (0)22 58 60 00
tord.ivarsson@r-bup.no

Sponsor type

Research organisation

Website

http://www.r-bup.no/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The participating clinics finance their participation from local funding agencies

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25358486
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25721185

Publication citations

Additional files

Editorial Notes

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.