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

NCT00994786 | Completed Phase 4

• 1 other identifier: 06-273
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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%. Augmentation strategies would be beneficial to maximize treatment response in OCD. 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

Keywords

treatment-resistant; refractory; obsessive compulsive disorder; Lyrica; pregabalin; Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Yale-Brown-Obsessive-Compulsive-Scale

  Baseline(Week 0) and Weeks 5, 9 and 12 (13 weeks)

• Clinical Global Impression - Improvement

  Weeks 1, 3, 5, 7, 9 and 12 (12 weeks)

Secondary Outcomes (7)

• Montgomery Asberg Depression Rating Scale

  Baseline (Week 0) (once - 1 week)

• Sheehan Disability Scale

  Baseline (Week 0) and Weeks 5, 9 and 12 (13 weeks)

• Beck Depression Inventory

  Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)

• Clinical Global Impression - Severity

  Baseline (Week 0) and Weeks 1, 3, 5, 7, 9 and 12 (13 weeks)

• Saving Inventory - Revised

  Weeks 1, 5, 9 and 12 (12 weeks)

Study Arms (2)

pregabalin

EXPERIMENTAL

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin DRUG

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.

Also known as: Lyrica

pregabalin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• McMaster University: lead
• Pfizer: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Van Ameringen, MD, FRCPC

  McMaster Univeristy, Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

• Dan Stein

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 14, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

CA (1)