Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotie Therapies Inc.
With
Syneos Health
This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
