Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
NCT00413010
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- Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
- Historical failure to respond optimally to a GAD treatment
- Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th
edition) diagnosis of major depressive disorder with or without seasonal pattern,
dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia,
panic disorder with or without agoraphobia, post traumatic stress disorder,
dissociative disorder, borderline personality disorder, obsessive-compulsive disorder,
antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and
Statistical Manual of Mental Disorders 4th edition, Text Revision).
- Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other
psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive
disorder (including delirium, dementia, and amnestic disorder).
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Descriptive Information | ||||
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Brief Title ICMJE | Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD). | |||
Official Title ICMJE | An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD) | |||
Brief Summary | The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures. | |||
Detailed Description | Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Generalized Anxiety Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Rickels K, Shiovitz TM, Ramey TS, Weaver JJ, Knapp LE, Miceli JJ. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012 May;27(3):142-50. doi: 10.1097/YIC.0b013e328350b133. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 356 | |||
Original Enrollment ICMJE | 350 | |||
Actual Study Completion Date ICMJE | March 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Czech Republic, Estonia, Finland, Hungary, Russian Federation, Serbia, Ukraine, United States | |||
Removed Location Countries | Former Serbia and Montenegro, Romania | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00413010 | |||
Other Study ID Numbers ICMJE | A0081103 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |