Obsessive Compulsive DisorderPhase 4NCT00708240
Treatment Youth With Obsessive-Compulsive Disorder
A Phase 4 study testing Escitalopram in people with Obsessive Compulsive Disorder, run by University of Ottawa at 1 site in Canada.
Trial summary
Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit specific deficits in their high cognitive processes, it is still unknown how these deficits relate to the clinical symptoms of the disorder, and to the response to treatment. There are two aims for the proposed research. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 4
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be 13 to 19 years old
- Have at least average intellectual ability
- Currently meet DSM-IV-TR criteria for OCD, upon completion of the Anxiety Disorder Interview Schedule for DSM-IV - Research and Lifetime Version for child and parent (ADIS- RLV)
- Receive a total score equal to or greater than 20 on the CY-BOCS at the screening visit have less than 25% decrease on the CY-BOCS total score between the screening and baseline visit
- If female of childbearing potential and sexually active in a heterosexual relationship, the subject must be using a reliable method of contraception, such as hormonal contraceptives
- Oral contraceptives must have been started at least 3 months prior to the start of the study
Who cannot join
- Clinically significant and/or unstable medical condition, including cardiovascular, respiratory, hematological, neurological and endocrine diseases
- History of neurological disorder or head injury
- Current use of medication with central nervous system effects
- Substance abuse or dependence within 6 months prior to enrolment
- Contra-indication to the fMRI
- Color blindness
Show all 13Show fewer
- A comorbid current DSM-IV Axis I diagnosis, except for tic disorders and another anxiety disorder, as long as the associated disorder is less disabling than the primary diagnosis of OCD, as can be assessed with the ADIS
- Patients who would require additional psychological or pharmacological treatment
- Significant suicide risk, based on clinical judgment and the relevant section of the ADIS
- Hypersensitivity to escitalopram
- Previous non-response to an adequate trial of escitalopram
- Any lifetime psychiatric disorder as assessed on the ADIS
- A lifetime diagnosis of schizophrenia in biological parents or siblings
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario, K1Z7K4
Zul Merali, PhD, 613-722-6521 ext. 6551, zul.merali@rohcg.on.ca
Martine F. Flament, MD
About this study
Official title: Treatment With Escitalopram (Cipralex®) for Adolescents With Obsessive-Compulsive Disorder: Efficacy, Safety, and Changes in Executive Functions, Metacognition, and Regional Brain Activations.
Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit specific deficits in their high cognitive processes, it is still unknown how these deficits relate to the clinical symptoms of the disorder, and to the response to treatment. There are two aims for the proposed research. The first is to examine how high cognitive processes and brain activity are affected in OCD. The second aim is to investigate the effects of a specific psychotropic medication (escitalopram) on high cognitive processes and brain activity in OCD. We will investigate how 40 youth with OCD (recruited in specialized clinics) differ from 40 healthy youth (recruited from the local community) on selected cognitive tests and brain imaging paradigms, as well as explore how treatment with medication can correct or reverse the observed differences. The final goal of our research is to learn more about the mechanisms of action for available treatments, in order to refine and improve short- and long-term therapeutic strategies for a highly debilitating and often lifelong disorder.
Read the detailed description
Rationale. Obsessive-compulsive disorder (OCD) often has a childhood onset, and is characterized by recurrent obsessions and compulsions that are perceived as irrational and cause significant interference in daily functioning. Neuropsychological and/or neuroimaging investigations have consistently implicated pathways involving the ventral prefrontal cortical regions in the pathophysiology of the disorder. In the absence of attention or memory loss, OCD patients perform more poorly than controls on tasks requiring inhibition of an automatic response. Dysfunction of a frontal-striatal-thalamic circuit in OCD may be mediated by abnormalities in glutamatergic-serotonin neurotransmission, and selective serotonin reuptake inhibitors (SSRIs) are the unique class of psychotropic medication with demonstrated efficacy for youth (and adults) with the disorder.
Objectives and hypotheses. The first objective of the study is to examine how executive functions, metacognition performance, and regional brain activations differ in adolescents with OCD compared to healthy controls. Three specific hypotheses will be tested: (1) in adolescents with OCD, the executive functions related to the frontal cortex will be impaired compared to healthy controls; (2) the metacognition performance of the OCD group will be lower than that of the control group; (3) using fMRI, the OCD group's frontal lobe activations during tasks testing response inhibition and working memory, will be higher than those in the control group. The second objective is to investigate how treatment with the SSRI escitalopram will affect executive functions, metacognition performance, and regional brain activations in adolescents with OCD. After pharmacotherapy, three specific hypotheses will be tested: (1) there will be significant improvement from baseline in the OCD group's frontal executive functions and metacognition performance; (2) the differences on executive functions and metacognition performance between the OCD and control groups will no longer be significant; (3) on repeated fMRI procedures, the OCD group's frontal lobe activations will show a significant decrease from baseline. The third objective is to explore, within the patient group, the relationships between the degree of clinical change, and the magnitude of pre-post-treatment changes in neurocognitive performance, and regional brain activations. The hypothesis is that greater clinical improvement will be associated with greater changes on the selected neurocognitive and neurofunctional measures.
Method. Forty subjects, aged 13-19 years, with a primary DSM-IV diagnosis of OCD, and 40 sex-, and age-matched healthy controls, will be recruited from Ottawa mental health centers and the community. The study will use a pre- post-treatment design, and include three phases. Phase I: Pre-treatment, the OCD subjects will be compared to controls on clinical, neurocognitive, and functional brain activation measures. Phase II: The OCD subjects will receive open treatment with escitalopram (5 mg to 20 mg/day) for 16 weeks. Phase III: The clinical, neurocognitive, and functional brain activations measures will be repeated in all OCD subjects who completed 16 weeks of escitalopram pharmacotherapy, and the neurocognitive measures in control participants after 16 weeks. The Wisconsin Card Sorting Test, Stroop Test, and a Working Memory Task will be used to assess frontal executive functions. The Feeling-of-knowing task and Metacognition Questionnaire will measure metacognition performances. To investigate regional brain activations (only in participants aged 15-19 years), two functional neuroimaging paradigms will be used, a Go/NoGo and a n-Back task, and regional brain activations will be measured using fMRI technology. In patients, clinical severity and changes with treatment will be assessed using the Children's Yale Brown Obsessive-Compulsive Scale, the Maudsley Obsessive-Compulsive Inventory, the State-Trait Anxiety Inventory for Children, and the Children Depression Inventory. Statistical methods will include repeated measures MANOVAS, t-tests, and correlational analyses.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Escitalopram
- 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.
EscitalopramDrug
Also called Cipralex
Escitalopram will be provided in unit doses commercially available, with a starting dose, minimum effective dose, and maximum effective dose of 5 mg, 10 mg and 20 mg, respectively, given once daily.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale-Brown Obsessive Compulsive Scale score.
Measured: Before and after treatment and at each study visit
Secondary outcomes (1)
Clinical Global Impression for Severity of Illness and Improvement
Measured: each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2007
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Martine F. Flament, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708240
- Sponsor's protocol ID
- IMHR-REB-2006-14
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Escitalopram (Cipralex®) for Adolescents With Obsessive-Compulsive Disorder: Efficacy, Safety, and Changes in Executive Functions, Metacognition, and Regional Brain Activations.
- ClinicalTrials.gov ID
- NCT00708240
- Acronym / sponsor ID
- IMHR-REB-2006-14
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Jan 2007
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Jul 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.
Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit specific deficits in their high cognitive processes, it is still unknown how these deficits relate to the clinical symptoms of the disorder, and to the response to treatment. There are two aims for the proposed research. The first is to examine how high cognitive processes and brain activity are affected in OCD. The second aim is to investigate the effects of a specific psychotropic medication (escitalopram) on high cognitive processes and brain activity in OCD. We will investigate how 40 youth with OCD (recruited in specialized clinics) differ from 40 healthy youth (recruited from the local community) on selected cognitive tests and brain imaging paradigms, as well as explore how treatment with medication can correct or reverse the observed differences. The final goal of our research is to learn more about the mechanisms of action for available treatments, in order to refine and improve short- and long-term therapeutic strategies for a highly debilitating and often lifelong disorder.
Detailed description
Rationale. Obsessive-compulsive disorder (OCD) often has a childhood onset, and is characterized by recurrent obsessions and compulsions that are perceived as irrational and cause significant interference in daily functioning. Neuropsychological and/or neuroimaging investigations have consistently implicated pathways involving the ventral prefrontal cortical regions in the pathophysiology of the disorder. In the absence of attention or memory loss, OCD patients perform more poorly than controls on tasks requiring inhibition of an automatic response. Dysfunction of a frontal-striatal-thalamic circuit in OCD may be mediated by abnormalities in glutamatergic-serotonin neurotransmission, and selective serotonin reuptake inhibitors (SSRIs) are the unique class of psychotropic medication with demonstrated efficacy for youth (and adults) with the disorder.
Objectives and hypotheses. The first objective of the study is to examine how executive functions, metacognition performance, and regional brain activations differ in adolescents with OCD compared to healthy controls. Three specific hypotheses will be tested: (1) in adolescents with OCD, the executive functions related to the frontal cortex will be impaired compared to healthy controls; (2) the metacognition performance of the OCD group will be lower than that of the control group; (3) using fMRI, the OCD group's frontal lobe activations during tasks testing response inhibition and working memory, will be higher than those in the control group. The second objective is to investigate how treatment with the SSRI escitalopram will affect executive functions, metacognition performance, and regional brain activations in adolescents with OCD. After pharmacotherapy, three specific hypotheses will be tested: (1) there will be significant improvement from baseline in the OCD group's frontal executive functions and metacognition performance; (2) the differences on executive functions and metacognition performance between the OCD and control groups will no longer be significant; (3) on repeated fMRI procedures, the OCD group's frontal lobe activations will show a significant decrease from baseline. The third objective is to explore, within the patient group, the relationships between the degree of clinical change, and the magnitude of pre-post-treatment changes in neurocognitive performance, and regional brain activations. The hypothesis is that greater clinical improvement will be associated with greater changes on the selected neurocognitive and neurofunctional measures.
Method. Forty subjects, aged 13-19 years, with a primary DSM-IV diagnosis of OCD, and 40 sex-, and age-matched healthy controls, will be recruited from Ottawa mental health centers and the community. The study will use a pre- post-treatment design, and include three phases. Phase I: Pre-treatment, the OCD subjects will be compared to controls on clinical, neurocognitive, and functional brain activation measures. Phase II: The OCD subjects will receive open treatment with escitalopram (5 mg to 20 mg/day) for 16 weeks. Phase III: The clinical, neurocognitive, and functional brain activations measures will be repeated in all OCD subjects who completed 16 weeks of escitalopram pharmacotherapy, and the neurocognitive measures in control participants after 16 weeks. The Wisconsin Card Sorting Test, Stroop Test, and a Working Memory Task will be used to assess frontal executive functions. The Feeling-of-knowing task and Metacognition Questionnaire will measure metacognition performances. To investigate regional brain activations (only in participants aged 15-19 years), two functional neuroimaging paradigms will be used, a Go/NoGo and a n-Back task, and regional brain activations will be measured using fMRI technology. In patients, clinical severity and changes with treatment will be assessed using the Children's Yale Brown Obsessive-Compulsive Scale, the Maudsley Obsessive-Compulsive Inventory, the State-Trait Anxiety Inventory for Children, and the Children Depression Inventory. Statistical methods will include repeated measures MANOVAS, t-tests, and correlational analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be 13 to 19 years old
- Have at least average intellectual ability
- Currently meet DSM-IV-TR criteria for OCD, upon completion of the Anxiety Disorder Interview Schedule for DSM-IV - Research and Lifetime Version for child and parent (ADIS- RLV)
- Receive a total score equal to or greater than 20 on the CY-BOCS at the screening visit have less than 25% decrease on the CY-BOCS total score between the screening and baseline visit
- If female of childbearing potential and sexually active in a heterosexual relationship, the subject must be using a reliable method of contraception, such as hormonal contraceptives
Key exclusion criteria (13 listed)
- Clinically significant and/or unstable medical condition, including cardiovascular, respiratory, hematological, neurological and endocrine diseases
- History of neurological disorder or head injury
- Current use of medication with central nervous system effects
- Substance abuse or dependence within 6 months prior to enrolment
- Contra-indication to the fMRI
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 |
|---|---|---|
| EscitalopramAlso: CipralexEscitalopram will be provided in unit doses commercially available, with a starting dose, minimum effective dose, and maximum effective dose of 5 mg, 10 mg and 20 mg, respectively, given once daily. | Drug | Escitalopram |
Primary outcome
Children's Yale-Brown Obsessive Compulsive Scale score.
Time frame: Before and after treatment and at each study visit
1 secondary outcome
Clinical Global Impression for Severity of Illness and Improvement
Time frame: each study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
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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.
Martine F. Flament, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Obsessive Compulsive Disorder, run by University of Ottawa at 1 site in Canada.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Jul 2008. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine F Flament, MD (613-722-6521 ext. 6455, martine.flament@rohcg.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale-Brown Obsessive Compulsive Scale score. (time frame: Before and after treatment and at each study visit). 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 2 Jul 2008.