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

Completed · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT00595231

Run by

Biotie Therapies Inc.

People needed

239

Starts

2008-03-01

Expected to finish

2008-10-01

Last updated by the study team

2019-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Carmen Research — Atlanta, Georgia, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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