Obsessive-Compulsive DisorderNCT00748761
Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
A study testing Cognitive Behavioral Therapy (CBT) and Waitlist in people with Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 31 Dec 2016
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Meets DSM-IV diagnostic criteria for OCD as primary diagnosis, based on the Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
- Clinical Global Impressions severity score of at least 4, reflecting moderately ill or worse status
- Children's Yale-Brown Obsessive Compulsive Scale total score of greater than or equal to 16
- No medication for OCD or other psychiatric condition in the past 4 weeks and no use of fluoxetine for the past 6 weeks
- Child is fluent in English
- Parental informed consent and child or adolescent informed assent forms are signed
- For females of childbearing potential a negative pregnancy test will be required for study entry
Who cannot join
- IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
- A lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
- Current DSM-IV diagnosis of major depressive disorder or attention deficit hyperactivity disorder any subtype, assessed through an ADIS rating of 4 or higher
- Any serious psychiatric, psychosocial, or neurological condition, such as a tic disorder, non-OCD anxiety, aggression, or family discord, that requires immediate treatment other than that provided in the current study
- One or more failed adequate trials of exposure-based CBT, defined as at least 10 sessions of therapist-assisted, exposure-based CBT with which the patient voluntarily complied
- More than one failed selective serotonin reuptake inhibitor trial adequate in dose and duration, defined as at least 8 weeks of treatment with at least 20 mg of fluoxetine, 20 mg of paroxetine, 75 mg of sertraline or fluvoxamine, or 75mg of clomipramine
- Any body metal (other than dental fillings), pregnancy, or other contraindications to MRSI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Child Psychiatry
Los Angeles, California, 90024
About this study
Official title: Cognitive-Behavioral Therapy & Glutamatergic Neurometabolites in Pediatric OCD
This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment.
Read the detailed description
Obsessive-compulsive disorder (OCD) afflicts 2% to 4% of children and adolescents, who suffer from persistent, unwanted thoughts and repetitive behaviors. One of the most effective treatments of OCD is cognitive behavioral therapy (CBT), yet researchers do not know how CBT affects the brain. In this study, brain scans will be performed to determine concentrations of several neurometabolites, which are chemicals involved in providing energy to the brain. Of particular importance are the neurometabolites glutamine and glutamate, which, in addition to providing energy to the brain, are among the most common excitatory neurotransmitters. Disruption of glutamine and glutamate is thought to be related to OCD. By examining where in the brain levels of glutamate and glutamine change, researchers will attempt to determine whether CBT modifies brain activity, whether a circuit targeted by researchers is affected by CBT, and how brain activity in people with OCD differs from that of people without the disorder in terms of the targeted circuit.
Children and adolescents ages 8 through 17 with OCD will be randomly assigned to either receive a 12-week CBT intervention or be placed on a waiting list for 8 weeks before receiving the 12-week intervention. A group of non-OCD participants in the same age group will be used as a control. All groups will undergo magnetic resonance spectroscopic imaging (MRSI), which will measure the concentrations of neurometabolites in multiple brain regions. The control group and the group initially given the CBT intervention will be scanned upon entry of the study and after 12 weeks. The group initially placed on a waiting list will be scanned three times: once upon entry, once after the 8-week waiting period, and once after the 12-week CBT intervention. To determine which participants are benefitting from the treatment, the Yale-Brown Obsessive-Compulsive Scale and other clinical and neurocognitive measures will be administered concurrently with each brain scan.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT), Waitlist
- Keywords
- Obsessive-Compulsive Disorder, OCD, Cognitive-Behavioral Therapy, CBT, MRSI, Glutamate
- 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.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called Behavioral therapy, Psychotherapy, Exposure and response prevention
Nondrug psychotherapy administered weekly for 12 weeks
WaitlistBehavioural
Also called Waiting for treatment, In line for treatment
Contact waitlist weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| OCD Active CBT | Experimental | Children with obsessive-compulsive disorder (OCD) will be treated with cognitive behavioral therapy (CBT) from the time of enrollment. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| OCD Waitlist | Active comparator | Children with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Waitlist |
| Healthy Controls | No intervention | Healthy control children will be given no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI)
Measured: 14 weeks
Secondary outcomes (1)
Overall score on child Yale-Brown Obsessive-Compulsive Scale
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJun 2008
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joseph O'Neill, PhD, National Institute of Mental Health (NIMH)
- Investigators
- Joseph O'Neill, PhD, Principal investigator, UCLA Child PsychiatryJohn C. Piacentini, PhD, Principal investigator, UCLA Child Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748761
- Sponsor's protocol ID
- R01MH081864
- Other IDs
- R01MH081864, DDTR B2-NDO
- Status last verified
- Mar 2020
- First submitted
- 8 Sep 2008
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy & Glutamatergic Neurometabolites in Pediatric OCD
- ClinicalTrials.gov ID
- NCT00748761
- Acronym / sponsor ID
- R01MH081864
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, OCD, Cognitive-Behavioral Therapy, CBT, MRSI, Glutamate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2008 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Sep 2008 (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.
This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment.
Detailed description
Obsessive-compulsive disorder (OCD) afflicts 2% to 4% of children and adolescents, who suffer from persistent, unwanted thoughts and repetitive behaviors. One of the most effective treatments of OCD is cognitive behavioral therapy (CBT), yet researchers do not know how CBT affects the brain. In this study, brain scans will be performed to determine concentrations of several neurometabolites, which are chemicals involved in providing energy to the brain. Of particular importance are the neurometabolites glutamine and glutamate, which, in addition to providing energy to the brain, are among the most common excitatory neurotransmitters. Disruption of glutamine and glutamate is thought to be related to OCD. By examining where in the brain levels of glutamate and glutamine change, researchers will attempt to determine whether CBT modifies brain activity, whether a circuit targeted by researchers is affected by CBT, and how brain activity in people with OCD differs from that of people without the disorder in terms of the targeted circuit.
Children and adolescents ages 8 through 17 with OCD will be randomly assigned to either receive a 12-week CBT intervention or be placed on a waiting list for 8 weeks before receiving the 12-week intervention. A group of non-OCD participants in the same age group will be used as a control. All groups will undergo magnetic resonance spectroscopic imaging (MRSI), which will measure the concentrations of neurometabolites in multiple brain regions. The control group and the group initially given the CBT intervention will be scanned upon entry of the study and after 12 weeks. The group initially placed on a waiting list will be scanned three times: once upon entry, once after the 8-week waiting period, and once after the 12-week CBT intervention. To determine which participants are benefitting from the treatment, the Yale-Brown Obsessive-Compulsive Scale and other clinical and neurocognitive measures will be administered concurrently with each brain scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCD Active CBT | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)Children with obsessive-compulsive disorder (OCD) will be treated with cognitive behavioral therapy (CBT) from the time of enrollment. |
| OCD Waitlist | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: WaitlistChildren with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT. |
| Healthy Controls | No intervention | –Healthy control children will be given no intervention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Meets DSM-IV diagnostic criteria for OCD as primary diagnosis, based on the Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
- Clinical Global Impressions severity score of at least 4, reflecting moderately ill or worse status
- Children's Yale-Brown Obsessive Compulsive Scale total score of greater than or equal to 16
- No medication for OCD or other psychiatric condition in the past 4 weeks and no use of fluoxetine for the past 6 weeks
- Child is fluent in English
Key exclusion criteria (7 listed)
- IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
- A lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
- Current DSM-IV diagnosis of major depressive disorder or attention deficit hyperactivity disorder any subtype, assessed through an ADIS rating of 4 or higher
- Any serious psychiatric, psychosocial, or neurological condition, such as a tic disorder, non-OCD anxiety, aggression, or family discord, that requires immediate treatment other than that provided in the current study
- One or more failed adequate trials of exposure-based CBT, defined as at least 10 sessions of therapist-assisted, exposure-based CBT with which the patient voluntarily complied
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 |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: Behavioral therapy, Psychotherapy, Exposure and response preventionNondrug psychotherapy administered weekly for 12 weeks | Behavioural | OCD Active CBT, OCD Waitlist |
| WaitlistAlso: Waiting for treatment, In line for treatmentContact waitlist weekly for 12 weeks | Behavioural | OCD Waitlist |
Primary outcome
Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI)
Time frame: 14 weeks
1 secondary outcome
Overall score on child Yale-Brown Obsessive-Compulsive Scale
Time frame: 14 weeks
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 25 Mar 2020.
Related trials for Obsessive-Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
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.
Joseph O'Neill, PhD principal investigator
UCLA Child Psychiatry
John C. Piacentini, PhD principal investigator
UCLA Child Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Waitlist in people with Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
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 7 inclusion and 7 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 25 Mar 2020. 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 United States. 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?
Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.