Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotie Therapies Inc.
• Collaborators: INC Research; Syneos Health
• Treatments: Rufinamide

Criteria

Inclusion Criteria:

• Outpatient 18-65

• Meet Diagnostic and Statistical Manual,(DSM) IV criteria for GAD

• Have moderate to severe anxiety

• Sign IRB (Institutional Review Board) approved consent and can comply with visits and procedures

• Women of childbearing potential must use acceptable method of contraception

Exclusion Criteria:

• Have diagnosis of adjustment disorder or anxiety disorder Not otherwise specified (NOS)

• Have diagnosis of specific phobia

• Have diagnosis of antisocial personality disorder or other Axis II Disorder

• Have diagnosis of substance abuse disorder within 3 months of study entry

• Have diagnosis of major depressive disorder or panic disorder within 6 months of study entry

• Have diagnosis of PTSD, eating disorder substance dependence disorder within 12 months of study entry

• Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder, bipolar mood disorder, Obsessive-Compulsive Disorder (OCD), psychosurgery

• Require medication to treat GAD other than study medication

• Failed to show improvement with past treatment for GAD

• Excessively consume caffeine

• Are receiving treatment with prohibited medications

• Uncontrolled thyroid condition

• Positive urine drug screen

• Obese

• Clinically significant ECG finding

• Participating in other clinical trial

• Clinically significant out of range lab value

• Past exposure to rufinamide

• Pregnant or nursing females