Obsessive Compulsive DisorderPhase 4NCT00116532
Escitalopram for the Treatment of Obsessive Compulsive Disorder (OCD)
A Phase 4 study testing Escitalopram in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of Escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Escitalopram
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Feb 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD by DSM-IV
- Age 18-65
- Y-BOCS greater than 20
- Written informed consent
- Females of childbearing potential must have a negative serum or urinary beta-HCG test.
Who cannot join
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- History of seizure disorder
- Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
- If there is a history of substance abuse, patients in remission at least 6 months.
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- Currently being treated with behavioral therapy, specifically exposure and response prevention, for OCD.
- Other medications for medical disorders that may interfere with escitalopram
- Current major depression or prescribed an antidepressant for major depression within the past 12 months.
- Taken an SSRI medication within 2 weeks of beginning the study (4 weeks for fluoxetine).
- More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another SSRI in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - OCD Clinic
Charlestown, Massachusetts, 02129
About this study
Official title: Escitalopram for the Treatment of Obsessive Compulsive Disorder
The purpose of this study is to assess the efficacy of Escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose.
Read the detailed description
Background and Purpose: Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. A recent double-blind, placebo-controlled trial demonstrated that citalopram is effective in the treatment of OCD. Escitalopram is a new SSRI that may be more effective than other SSRIs for the treatment of major depression and may have fewer side effects. This study aims to assess the efficacy of escitalopram for the treatment of OCD.
Comparisons: Subject Y-BOCs pre-post treatment. We will also compare the improvement of subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Escitalopram
- Keywords
- Obsessive Compulsive Disorder, Escitalopram, SSRI, Open Label
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-BOCs scores at 1st and last visit (16 weeks later)
Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)
Secondary outcomes (4)
HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
QLESQ - first and last visit (week 0 and 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startOct 2002
- Study completionFeb 2007
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 Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Darin D Dougherty, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116532
- Sponsor's protocol ID
- 2002-P-000895
- Other IDs
- LXP-MD-14, 1200-211220
- Status last verified
- Apr 2007
- First submitted
- 29 Jun 2005
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram for the Treatment of Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00116532
- Acronym / sponsor ID
- 2002-P-000895
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Escitalopram, SSRI, Open Label
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Oct 2002
- Study completion
- Feb 2007 (actual)
- First posted
- 30 Jun 2005 (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.
The purpose of this study is to assess the efficacy of Escitalopram in the treatment of obsessive compulsive disorder and to determine the optimal treatment dose.
Detailed description
Background and Purpose: Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors, and behavioral therapy. A recent double-blind, placebo-controlled trial demonstrated that citalopram is effective in the treatment of OCD. Escitalopram is a new SSRI that may be more effective than other SSRIs for the treatment of major depression and may have fewer side effects. This study aims to assess the efficacy of escitalopram for the treatment of OCD.
Comparisons: Subject Y-BOCs pre-post treatment. We will also compare the improvement of subjects across the three different medication levels: 10 mg, 20 mg, and 30 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of OCD by DSM-IV
- Age 18-65
- Y-BOCS greater than 20
- Written informed consent
- Females of childbearing potential must have a negative serum or urinary beta-HCG test.
Key exclusion criteria (11 listed)
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- History of seizure disorder
- Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Y-BOCs scores at 1st and last visit (16 weeks later)
Clinical Global impressions Scale at 2nd visit (2 weeks after 1st visit) and 6th visit (16 weeks post 1st visit)
4 secondary outcomes
HAMD - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BDI - first and last visit (Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
BAI - first and last visit Given week 0, 2, 4, 8, 12, & 16. Comparisons from week 0 and 16)
QLESQ - first and last visit (week 0 and 16)
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 Apr 2007.
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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.
Darin D Dougherty, MD principal investigator
Massachusetts General Hospital
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 Massachusetts General Hospital 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 5 inclusion and 11 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 Apr 2007. 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.
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?
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?
Y-BOCs scores at 1st and last visit (16 weeks later). 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?
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 Apr 2007.