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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 RESPOND...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-006339-31

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

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Extrait

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo as an adjunctive treatment in patients with GAD who partially responded to a standard GAD treatment. Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM A) scores from baseline (Visit 8, Week 0) observed following 8 weeks of double blind treatment (Visit 15, Week 8 or at earlier termination during the double blind treatment phase) and analyzed using a mixed linear model for repeated measures.

Critère d'inclusion

  • Generalized Anxiety Disorder (GAD)

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