Phase 3
Completed N=356
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
Source: ClinicalTrials.gov NCT00413010 ↗Enrolled (actual)
356
Serious AEs
—
Results posted
Dec 2009
Primary outcomePrimary: Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores — -7.6; -6.4 score on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores |
-7.6; -6.4 | — |
| SECONDARY Change in HAM-A Total Score at Weekly Visits |
-4.4; -3.1; -6.3; -5.2; -7.0; -5.5 | — |
| SECONDARY Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) |
21; 8; 143; 161; 39; 26 | — |
| SECONDARY Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score |
12; 5; 152; 164; 22; 15 | — |
| SECONDARY Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement |
57 | 0.0137 sig |
| SECONDARY Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score |
62; 49; 101; 120; 94; 74 | — |
| SECONDARY Clinical Global Impression of Severity (CGI-S) Score |
28; 18; 49; 37; 49; 63 | — |
| SECONDARY Change in Hamilton Depression Rating Scale (HAM-D) Total Score |
-2.1; -1.3; -3.1; -2.4; -3.5; -2.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00413010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.