Obsessive-Compulsive DisorderSMARTNCT01148316
Developing Adaptive Treatment Strategies for Children and Adolescents With Obsessive-compulsive Disorder.
A study testing fluoxetine and Group cognitive-behavioral therapy in people with Obsessive-Compulsive Disorder, run by Roseli Shavitt at 1 site in Brazil.
Trial summary
Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its onset during childhood or adolescence and is potentially incapacitating. If not properly treated, this disorder tends to follow a chronic course. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- fluoxetine and Group cognitive-behavioral therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of obsessive-compulsive disorder according to DSM-IV as major problem
- 7 to 17 years
- who agree to participate in the research
- who have parental permission or legal guardian to participate in the research
- that do not have physical or cognitive impairments that prevent the participation of research
- YBOCS ≥ 16 for obsession and compulsion or ≥ 10 for only obsession or compulsion only
- Be above the tenth percentile of weight corresponding to age
- IQ greater than 80 - assessed using the Raven (the screening, if necessary)
Who cannot join
- Inability to study evaluated adherence to the beginning.
- ANY medical or neurological condition that determines contraindication to any of the treatments or that may influence the evaluation protocol
- pregnancy (women of childbearing age should use contraception)
- Suicidal ideation (with intent) CURRENT
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institue of Psychiatry - Hospital of Clinics - University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its onset during childhood or adolescence and is potentially incapacitating. If not properly treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not benefit from these treatments, and the presence of residual symptoms is frequent among treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line treatment for pediatric OCD, either administered in individual or group format. There is evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no data on adaptive treatment strategies regarding such treatments on the long term outcome of OCD patients. The aim of this study is to verify, in a randomized design, if there is an optimal sequential treatment strategy for pediatric OCD, adopting the two most studied treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are: (1) both types of treatment will present similar efficacy in the short term (14 weeks); (2) for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14 weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for additional 14 weeks) after additional 14 weeks.
Read the detailed description
This is a 28-week open protocol, composed of two phases of randomized treatments with 14 weeks duration.
Inclusion criteria: DSM-IV diagnosis of OCD; age between 7 and 17 years; willing to participate in the protocol; parents or legal tutors agreement with their child participation in the protocol; absence of physical or cognitive impairment that prevent the participation in the protocol.
We expect to end the protocol with 50 patients in each arm (total = 200). For this reason, the purpose is to recruit at least 400 patients for the first randomization (R1: fluoxetine X group CBT). Responders to the initial type of treatment will be maintained in the same procedure for additional 14 weeks. The second randomization (R2) will address non-responders to fluoxetine, who will be randomized to switch to group CBT or receive group CBT as add-on therapy; and non-responders to group CBT, who will be randomized to switch to fluoxetine or receive fluoxetine as add-on therapy.
Fluoxetine will be administered in drops or capsules, in doses ranging from 10 to 80mg/day. Group CBT will be delivered weekly, in 2-hour sessions, in groups of 6 to 8 participants.
At the end of each treatment (weeks 14 and 28), treatment response will be assessed by blind raters, through the YBOCS and CGI-global improvement subscale. Response will be defined as at least 35% reduction in baseline YBOCS scores and a CGI score of 1 or 2.
Efficacy of treatments at the end of R1 will be compared and the efficacy of the different sequences of treatments at the end of R2 (adaptive treatment strategies) will be compared by means of an intention-to-treat analysis.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- fluoxetine, Group cognitive-behavioral therapy
- Keywords
- Developmental Psychiatry, Sequential Randomized Clinical Trial, Obsessive-Compulsive Disorder D009771
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
drops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks
Group cognitive-behavioral therapyBehavioural
weekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Active comparator | drops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks Receives: Drug: fluoxetine |
| Group cognitive-behavioral therapy | Active comparator | weekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks Receives: Behavioral: Group cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response status at week 28
The primary outcome will be the treatment response status, as measured by the variation of Yale-Brown Obsessive-Compulsive Scale,after having received,in a randomized design, different sequential treatments for obsessive-compulsive disorder.
Measured: Yale-Brown Obsessive-Compulsive Scale scores at week 28
Treatment response status at week 14
Treatment resposnse to the first treatment assigned, fluoxetine or group cognitive-behavioral therapy, will be assessed at week 14. Non- responders will be randomized to the second treatment: either combination therapy (fluoxetine plus group cognitive-behavioral therapy) or switch to the other first line treatment (non-responders to fluoxetine as the first treatment switch to group cognitive behavioral therapy and non-responders to cognitive behavioral therapy switch to fluoxetine)
Measured: Yale-Brown Obsessive Compulsive Scale Score at week 14
Secondary outcomes (1)
Predictors of treatment response at week 28
Socio-demographical and clinical factors, such as gender, age at onset of the disorder, duration of illness, obsessive-compulsive symptom dimensions, psychiatric comorbidities and family accomodation, will be analyzed in relation to the response to the distinct sequential treatments.
Measured: KID-SADS, Family Accomodation Scale, Dimensional Yael-Brown Obsessive-Compulsive Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roseli Shavitt
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pernambuco
- Responsible party
- Sponsor-investigator, Roseli Shavitt, University of Sao Paulo
- Investigators
- Euripedes Miguel, MD, PhD, Principal investigator, University of Sao PauloRoseli G Shavitt, MD, PhD, Study director, University of Sao PauloGuilherme V Polanczyk, MD, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148316
- Sponsor's protocol ID
- IPq-HCFMUSP - 259
- Acronym
- SMART
- Status last verified
- Oct 2014
- First submitted
- 2 Jun 2010
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vattimo EFQ, Barros VB, Requena G, Sato JR, Fatori D, Miguel EC, Shavitt RG, Hoexter MQ, Batistuzzo MC. Caudate volume differences among treatment responders, non-responders and controls in children with obsessive-compulsive disorder. Eur Child Adolesc Psychiatry. 2019 Dec;28(12):1607-1617. doi: 10.1007/s00787-019-01320-w. Epub 2019 Apr 10.
PubMed 30972581
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
- ClinicalTrials.gov ID
- NCT01148316
- Acronym / sponsor ID
- SMART / IPq-HCFMUSP - 259
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Developmental Psychiatry, Sequential Randomized Clinical Trial, Obsessive-Compulsive Disorder D009771
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Roseli ShavittUniversity, hospital or other
- Collaborators
- University of Pernambuco
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its onset during childhood or adolescence and is potentially incapacitating. If not properly treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not benefit from these treatments, and the presence of residual symptoms is frequent among treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line treatment for pediatric OCD, either administered in individual or group format. There is evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no data on adaptive treatment strategies regarding such treatments on the long term outcome of OCD patients. The aim of this study is to verify, in a randomized design, if there is an optimal sequential treatment strategy for pediatric OCD, adopting the two most studied treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are: (1) both types of treatment will present similar efficacy in the short term (14 weeks); (2) for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14 weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for additional 14 weeks) after additional 14 weeks.
Detailed description
This is a 28-week open protocol, composed of two phases of randomized treatments with 14 weeks duration.
Inclusion criteria: DSM-IV diagnosis of OCD; age between 7 and 17 years; willing to participate in the protocol; parents or legal tutors agreement with their child participation in the protocol; absence of physical or cognitive impairment that prevent the participation in the protocol.
We expect to end the protocol with 50 patients in each arm (total = 200). For this reason, the purpose is to recruit at least 400 patients for the first randomization (R1: fluoxetine X group CBT). Responders to the initial type of treatment will be maintained in the same procedure for additional 14 weeks. The second randomization (R2) will address non-responders to fluoxetine, who will be randomized to switch to group CBT or receive group CBT as add-on therapy; and non-responders to group CBT, who will be randomized to switch to fluoxetine or receive fluoxetine as add-on therapy.
Fluoxetine will be administered in drops or capsules, in doses ranging from 10 to 80mg/day. Group CBT will be delivered weekly, in 2-hour sessions, in groups of 6 to 8 participants.
At the end of each treatment (weeks 14 and 28), treatment response will be assessed by blind raters, through the YBOCS and CGI-global improvement subscale. Response will be defined as at least 35% reduction in baseline YBOCS scores and a CGI score of 1 or 2.
Efficacy of treatments at the end of R1 will be compared and the efficacy of the different sequences of treatments at the end of R2 (adaptive treatment strategies) will be compared by means of an intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Active comparator | Drug: fluoxetinedrops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks |
| Group cognitive-behavioral therapy | Active comparator | Behavioral: Group cognitive-behavioral therapyweekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- diagnosis of obsessive-compulsive disorder according to DSM-IV as major problem
- 7 to 17 years
- who agree to participate in the research
- who have parental permission or legal guardian to participate in the research
- that do not have physical or cognitive impairments that prevent the participation of research
Key exclusion criteria (4 listed)
- Inability to study evaluated adherence to the beginning.
- ANY medical or neurological condition that determines contraindication to any of the treatments or that may influence the evaluation protocol
- pregnancy (women of childbearing age should use contraception)
- Suicidal ideation (with intent) CURRENT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluoxetinedrops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks | Drug | Fluoxetine |
| Group cognitive-behavioral therapyweekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks | Behavioural | Group cognitive-behavioral therapy |
Primary outcome
Treatment response status at week 28
Time frame: Yale-Brown Obsessive-Compulsive Scale scores at week 28
The primary outcome will be the treatment response status, as measured by the variation of Yale-Brown Obsessive-Compulsive Scale,after having received,in a randomized design, different sequential treatments for obsessive-compulsive disorder.
Treatment response status at week 14
Time frame: Yale-Brown Obsessive Compulsive Scale Score at week 14
Treatment resposnse to the first treatment assigned, fluoxetine or group cognitive-behavioral therapy, will be assessed at week 14. Non- responders will be randomized to the second treatment: either combination therapy (fluoxetine plus group cognitive-behavioral therapy) or switch to the other first line treatment (non-responders to fluoxetine as the first treatment switch to group cognitive behavioral therapy and non-responders to cognitive behavioral therapy switch to fluoxetine)
1 secondary outcome
Predictors of treatment response at week 28
Time frame: KID-SADS, Family Accomodation Scale, Dimensional Yael-Brown Obsessive-Compulsive Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Derived from this study: PubMed 30972581Vattimo EFQ, Barros VB, Requena G, Sato JR, Fatori D, Miguel EC, Shavitt RG, Hoexter MQ, Batistuzzo MC. Caudate volume differences among treatment responders, non-responders and controls in children with obsessive-compulsive disorder. Eur Child Adolesc Psychiatry. 2019 Dec;28(12):1607-1617. doi: 10.1007/s00787-019-01320-w. Epub 2019 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euripedes Miguel, MD, PhD principal investigator
University of Sao Paulo
Roseli G Shavitt, MD, PhD study director
University of Sao Paulo
Guilherme V Polanczyk, MD, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoxetine and Group cognitive-behavioral therapy in people with Obsessive-Compulsive Disorder, run by Roseli Shavitt at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response status at week 28 (time frame: Yale-Brown Obsessive-Compulsive Scale scores at week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.