OCDPhase 2NCT00215137

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

A Phase 2 study testing escitalopram in people with OCD, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: OCD
What is being tested?: escitalopram
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Oct 2004to Mar 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of OCD
A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

Who cannot join

Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
A primary diagnosis of another Axis I psychiatric disorder
Alcohol or other substance abuse or dependence within the last 6 months
Unstable medical condition
Clinically significant laboratory abnormality
Failure of a previous 10-week trial of citalopram of at least 40 mg/day or escitalopram 20 mg/day

Show all 12Show fewer

Active suicidality
History of violent behavior in the past year or current risk of serious violence
A history of sensitivity to citalopram or escitalopram
Use of other investigational drugs within 30 days of baseline or other psychotropic drugs or herbs within 14 days of baseline (28 days for fluoxetine)
Need for concurrent psychotherapeutic intervention
Pregnant or lactating females.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

Read the detailed description

OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.

This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.

Conditions: OCD
Being tested: escitalopram, Placebo ( sugar pill)
Keywords: OCD, SSRI, escitalopram, relapse
Medical subject headings: Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

escitalopramDrug
Also called Lexapro
Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.
Placebo ( sugar pill)Drug
Also called Placebo
Placebo Comparator in double.blind phase.

Study groups in NCT00215137
Study group	Role	What they receive
Open Label Escitalopram 10-20 mg/daily	Experimental	Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. Receives: Drug: escitalopram
Randomizationn Placebo 10-20 mg daily	Placebo comparator	Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). Receives: Drug: Placebo ( sugar pill)
Randomization Escitalopram 10-20 mg/daily	Active comparator	Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). Receives: Drug: escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Yale Brown Obsessive Compulsive Scale
The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.
Measured: Open Label Phase Baseline,Randomization Phase Baseline or Beginning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Mar 2009

First posted22 Sep 2005 (estimated)
Study startOct 2004
Primary completionJan 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OCDStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00215137
Sponsor's protocol ID: Pro00013150
Other IDs: 5731-04-4R0
Status last verified: Aug 2013
First submitted: 20 Sep 2005
Last updated: 23 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All OCD trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder
ClinicalTrials.gov ID: NCT00215137
Acronym / sponsor ID: Pro00013150
Conditions: OCD
Keywords: OCD, SSRI, escitalopram, relapse
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: Oct 2004
Primary completion: Jan 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 29 Oct 2013

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 determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Open Label Escitalopram 10-20 mg/daily	Experimental	Drug: escitalopramFourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
Randomizationn Placebo 10-20 mg daily	Placebo comparator	Drug: Placebo ( sugar pill)Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
Randomization Escitalopram 10-20 mg/daily	Active comparator	Drug: escitalopramOf the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of OCD
A minimum score of 16 on the Yale Brown Obsessive-Compulsive Scale (YBOCS) at both the screening and baseline visits

Key exclusion criteria (12 listed)

Lifetime history of psychosis or cognitive dysfunction due to a general medical condition or substance use
A primary diagnosis of another Axis I psychiatric disorder
Alcohol or other substance abuse or dependence within the last 6 months
Unstable medical condition
Clinically significant laboratory abnormality

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: LexaproOpen label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day.	Drug	Open Label Escitalopram 10-20 mg/daily, Randomization Escitalopram 10-20 mg/daily
Placebo ( sugar pill)Also: PlaceboPlacebo Comparator in double.blind phase.	Drug	Randomizationn Placebo 10-20 mg daily

Primary outcome

Yale Brown Obsessive Compulsive Scale
Time frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning
The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.

Results and safety

Results posted to the registry on 29 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Escitalopram	14	13
Randomization Placebo	0	0
Randomization Escitalopram	0	0

Primary outcome: Yale Brown Obsessive Compulsive Scale

Time frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning. Mean (Standard Deviation). Unit: units on a scale

Measure	Open Label Escitalopram n = 14	Randomization Placebo n = 7	Randomization Escitalopram n = 5
Beginning of Study Phase	24.79 (4.48)	12.71 (6.13)	16.00 (6.96)
End of Study Phase	15.36 (7)	20.17 (11.57)	15.8 (7.79)

Open Label Escitalopram: p = 0.0002, Wilcoxon (Mann-Whitney)
Randomization Placebo vs Randomization Escitalopram: p = .0417, Wilcoxon Rank Sum Test

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Escitalopram	0 of 14 (0%)	0 of 14 (0%)	Not reported
Randomization Placebo	0 of 7 (0%)	0 of 7 (0%)	Not reported
Randomization Escitalopram	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationC. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript

Related trials for OCD

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.

Wei M. Zhang, MD, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing escitalopram in people with OCD, run by Duke University 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 2 inclusion and 12 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 23 Jul 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Yale Brown Obsessive Compulsive Scale (time frame: Open Label Phase Baseline,Randomization Phase Baseline or Beginning). 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 NCT00215137, 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 23 Jul 2014.