Obsessive-Compulsive DisorderPhase 4NCT00994786

A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder

A Phase 4 study testing pregabalin in people with Obsessive-Compulsive Disorder, run by McMaster University at 1 site in Canada.

Completed

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

Official record

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Trial summary

This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for individuals who have not responded or only partially responded to an adequate trial of SRI. Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials, response rates have been as low as 40%. 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?: pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteCanada
Study dates: Jan 2009to Jan 2019
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

Must be an outpatient with a primary DSM-IV Obsessive-Compulsive Disorder. Patients must have a score of greater than 20 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman et al., 1989b).
Diagnosis of comorbid DSM-IV major depressive episode will be allowed in the study provided that the diagnosis is secondary to OCD, they have a baseline Montgomery Depression Rating Scale (MADRS) score of less than or equal to 19, and the onset of OCD predates the onset of the current episode of depression by five or more years.
The ability to comprehend and comply with protocol requirements.
Written consent must be provided prior to study entry.
All women of childbearing potential (WOCBP) must be practicing a medically acceptable method of birth control
All female subjects of childbearing potential (WOCBP), including those who are practicing a medically acceptable method of birth control, must have a negative serum pregnancy test within 72 hours prior to the start of study medication.

Who cannot join

Patients with any other primary DSM-IV psychiatric diagnosis in addition to Obsessive Compulsive Disorder.
Patients who currently fulfil criteria for DSM-IV eating disorder, body dysmorphic disorder, current alcohol or substance abuse, or who have a lifetime history of bipolar disorder. Patients with a history of Schizophrenia and other psychotic disorders, Delirium, Dementia, and Amnestic and other cognitive disorders.
Subjects with a concurrent Axis II Cluster A Personality Disorder
Borderline or Antisocial Personality Disorder.
Subjects who based on history or mental status examination have a significant risk of committing suicide, in the investigator's opinion.
Subjects with a history of more than three adequate trials with an SSRI.

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Subjects who have had an adequate trial of pregabalin.
Subjects who have initiated psychotherapy in the last 4 months prior to the first visit.
Subjects who, during the course of the study, would be likely to require treatment with prohibited concomitant therapy .
Prior use of or a known allergy or hypersensitivity to pregabalin.
Subjects who have participated in any clinical trial within 30 days prior to entering the study, or in a clinical trial involving a psychotropic medication within the 6 months prior to entering the study.
Any subject who has been taking benzodiazepines before entering the study who: 1) cannot tolerate being free of benzodiazepines for 4 weeks, or 2) has signs or symptoms of benzodiazepine withdrawal or rebound at the end of those 4 weeks. Should a patient entering the study, who is currently on benzodiazepines develop discontinuation symptoms with discontinuation of their benzodiazepine, we will treat these symptoms with a more gradual benzodiazepine taper. Study will be delayed until the patient is able to tolerate the discontinuation for 4 weeks.
Patients with a current seizure disorder, organic brain disorder or a history of seizure disorders (except for febrile seizures in childhood).
Patients with thyroid pathology, the treatment of which has not been stabilized for at least three months.
Patients on neuroleptic drugs in the two months prior to study entry or cognitive behavioural therapy specific to OCD within four weeks of study entry
Pregnant or lactating females, or if sexually active and of childbearing potential, not using adequate methods of birth control.
Patients with a history or evidence of a medical condition that would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the trial.
Patients receiving psychotropics of any kind, including betablockers and other anticonvulsants. Sleep medication such as oral chloral-hydrate or zopiclone are acceptable.
Patients using any herbal psychoactive treatments, e.g. St John's Wort, Valerian, Kava Kava, L-tryptophan.
Patients with any condition or on any therapy that, in the investigator's opinion, or as indicated in the pregabalin product label, may pose a risk to the subject.
Patients who have had a major life event in the past three months, which in the judgement of the investigator is influencing their current condition.
Patients having clinically significant abnormal laboratory, or ECG findings not resolved by further examinations.

Trial locations and contacts

1 site in 1 country.

Canada1 site

MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B7

Other trials in Canada

About this study

Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as well as inhibit glutamate release. These two neurotransmitters systems have been implicated in the neurobiology of OCD.

The study will consist of patients who have not attained full response to an SRI. The patients will be randomized in a double-blind fashion to augmentation with pregabalin (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side effects. Patients' response to treatment will be measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale(CGI).

Conditions: Obsessive-Compulsive Disorder
Being tested: pregabalin, Placebo
Keywords: treatment-resistant, refractory, obsessive compulsive disorder, Lyrica, pregabalin, Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder
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.

pregabalinDrug
Also called Lyrica
pregabalin starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin will be 600 mg/day.
PlaceboDrug
Placebo starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin/placebo will be 600 mg/day.

Study groups in NCT00994786
Study group	Role	What they receive
pregabalin	Experimental	Not described Receives: Drug: pregabalin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Yale-Brown-Obsessive-Compulsive-Scale
Measured: Baseline(Week 0) and Weeks 5, 9 and 12 (13 weeks)
Clinical Global Impression - Improvement
Measured: Weeks 1, 3, 5, 7, 9 and 12 (12 weeks)

Secondary outcomes (7)

Montgomery Asberg Depression Rating Scale
Measured: Baseline (Week 0) (once - 1 week)
Sheehan Disability Scale
Measured: Baseline (Week 0) and Weeks 5, 9 and 12 (13 weeks)
Beck Depression Inventory
Measured: Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)
Clinical Global Impression - Severity
Measured: Baseline (Week 0) and Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)
Saving Inventory - Revised
Measured: Weeks 1, 5, 9 and 12 (12 weeks)
Dimensional Yale-Brown-Obsessive Compulsive Scale (D-Y-BOCS)
Measured: Baseline (Week 0) and Weeks 1, 5 and 12 (13 weeks)
Padua Inventory
Measured: 13 weeks

Timeline

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

Jan 2009Jan 2019

First posted14 Oct 2009 (estimated)
Study startJan 2009
Primary completionJan 2019
Study completionJan 2019

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 McMaster 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00994786
Sponsor's protocol ID: 06-273
Status last verified: Jun 2019
First submitted: 5 Oct 2009
Last updated: 18 Jun 2019
Results posted: No
Data monitoring committee: No

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

Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
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Recruiting
Precision Analytic Research Methods in OCD
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)

All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder
ClinicalTrials.gov ID: NCT00994786
Acronym / sponsor ID: 06-273
Conditions: Obsessive-Compulsive Disorder
Keywords: treatment-resistant, refractory, obsessive compulsive disorder, Lyrica, pregabalin, Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: McMaster UniversityUniversity, hospital or other
Collaborators: Pfizer, Hamilton Health Sciences Corporation
Study start: Jan 2009
Primary completion: Jan 2019 (actual)
Study completion: Jan 2019 (actual)
First posted: 14 Oct 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
pregabalin	Experimental	Drug: pregabalin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must be an outpatient with a primary DSM-IV Obsessive-Compulsive Disorder. Patients must have a score of greater than 20 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman et al., 1989b).
Diagnosis of comorbid DSM-IV major depressive episode will be allowed in the study provided that the diagnosis is secondary to OCD, they have a baseline Montgomery Depression Rating Scale (MADRS) score of less than or equal to 19, and the onset of OCD predates the onset of the current episode of depression by five or more years.
The ability to comprehend and comply with protocol requirements.
Written consent must be provided prior to study entry.
All women of childbearing potential (WOCBP) must be practicing a medically acceptable method of birth control

Key exclusion criteria (22 listed)

Patients with any other primary DSM-IV psychiatric diagnosis in addition to Obsessive Compulsive Disorder.
Patients who currently fulfil criteria for DSM-IV eating disorder, body dysmorphic disorder, current alcohol or substance abuse, or who have a lifetime history of bipolar disorder. Patients with a history of Schizophrenia and other psychotic disorders, Delirium, Dementia, and Amnestic and other cognitive disorders.
Subjects with a concurrent Axis II Cluster A Personality Disorder
Borderline or Antisocial Personality Disorder.
Subjects who based on history or mental status examination have a significant risk of committing suicide, in the investigator's opinion.

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
pregabalinAlso: Lyricapregabalin starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin will be 600 mg/day.	Drug	pregabalin
PlaceboPlacebo starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin/placebo will be 600 mg/day.	Drug	Placebo

Primary outcome

Yale-Brown-Obsessive-Compulsive-Scale
Time frame: Baseline(Week 0) and Weeks 5, 9 and 12 (13 weeks)
Clinical Global Impression - Improvement
Time frame: Weeks 1, 3, 5, 7, 9 and 12 (12 weeks)

7 secondary outcomes

Montgomery Asberg Depression Rating Scale
Time frame: Baseline (Week 0) (once - 1 week)
Sheehan Disability Scale
Time frame: Baseline (Week 0) and Weeks 5, 9 and 12 (13 weeks)
Beck Depression Inventory
Time frame: Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)
Clinical Global Impression - Severity
Time frame: Baseline (Week 0) and Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)
Saving Inventory - Revised
Time frame: Weeks 1, 5, 9 and 12 (12 weeks)
Dimensional Yale-Brown-Obsessive Compulsive Scale (D-Y-BOCS)
Time frame: Baseline (Week 0) and Weeks 1, 5 and 12 (13 weeks)
Padua Inventory
Time frame: 13 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 18 Jun 2019.
Related InfoLink provided by the sponsor.

Related trials for Obsessive-Compulsive Disorder

Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
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)

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.

Michael Van Ameringen, MD, FRCPC principal investigator

McMaster Univeristy, Hamilton Health Sciences

Dan Stein principal investigator

University of Stellenbosch

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 pregabalin in people with Obsessive-Compulsive Disorder, run by McMaster University 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 22 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 18 Jun 2019. 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. 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 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?

Yale-Brown-Obsessive-Compulsive-Scale (time frame: Baseline(Week 0) and Weeks 5, 9 and 12 (13 weeks)). 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 NCT00994786.

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 18 Jun 2019.