Clinical trial NCT00595231: Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Official title: A Multi-Center,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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: GAD
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2008-01-16
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed
timeFrame: 8 Weeks
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics
timeFrame: 8 Weeks
measure: Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics.
timeFrame: 8 Weeks
measure: Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S)
timeFrame: 8 weeks
measure: Change From Baseline Raskin Depression Scale.
timeFrame: 8 weeks
measure: Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Carmen Research
state: Georgia
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
Study officials:
affiliation: Biotie Therapies Inc.
name: Christpher Kenney, MD
role: STUDY_CHAIR
References: