Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
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|ClinicalTrials.gov Identifier: NCT00595231|
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : January 23, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Drug: SYN111 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||March 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
500 mg 1 week, followed by 1000 mg for 7 weeks
500 mg for 1 week followed by 1000 mg for 7 weeks
Other Name: Rufinamide
Placebo Comparator: Placebo
0 mg tablets
0 mg tablets
- Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed [ Time Frame: 8 Weeks ]The Hamilton Anxiety Scale is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety). The interviewer then rated the individuals on a 5-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining 7 items address somatic anxiety. The total anxiety score ranges from 0 to 56. The 7 psychic anxiety items elicit a psychic anxiety score that ranges from 0 to 28. The remaining 7 items yield a somatic anxiety score that also ranges from 0 to 28. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity, a score of 25 to 30 indicates a moderate to severe anxiety and lastly a score of 31-56 is very severe. HAM-A total score is the sum of items 1 - 14.
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics [ Time Frame: 8 Weeks ]The Hospital Anxiety and Depression Scale is a self screening questionnaire for depression and anxiety. It consists of 14 questions, seven for anxiety and seven for depression. The 14 statements are relevant to either generalized anxiety (7 statements) or 'depression' (again 7). Each question has 4 possible responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The 2 subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into 4 ranges: normal (0-7), mild (8-10), moderate (11-15) and severe (16-21). Anxiety score = sum of items 1, 3, 5, 7, 9, 11, and 13. Depression score = sum of items 2, 4, 6, 8, 10, 12, and 14.
- Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics. [ Time Frame: 8 Weeks ]The MADRS (Montgomery and Asberg 1979) is a clinician-rated instrument that measures the presence and severity of depression. This instrument consists of 10 items. Each item is rated on a defined step scale of 0 to 6 with anchors at 2-point intervals. The MADRS total score is the sum of the 10 items and ranges from 0 to 60. A high numeric rating shows a greater degree of symptom severity.
- Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S) [ Time Frame: 8 weeks ]Severity of illness is the first scale in the CGI. A rating is filled in by the investigator at the start of treatment based on a 0-7 point weighted scale. It goes from not assessed (0), to among the most extremely ill patients (7).
- Change From Baseline Raskin Depression Scale. [ Time Frame: 8 weeks ]It explores the extent to which an individual demonstrates depression on three sub-scales (rated 1-5): verbal self-report, behavior and secondary symptoms of depression. Scores range from 3-15, with higher scores indicating greater severity.
- Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed [ Time Frame: 8 weeks ]
The Covi Anxiety Scale is a simple 3 item scale for the assessment of severity of anxiety symptoms. The scale measures 3 dimensions: verbal report, behavior and somatic symptoms of anxiety. Each item scored on a scale of 1 - 5. (1)not at all, (2)somewhat, (3)moderately, (4) considerably, and (5)very much), hence the scale is a 5- to 15 point range. The three items are the patient's verbal report (feeling shaky, jittery, jumpy), observed behavior consistent with anxiety during the interview (e.g. appearing frightened, shaky, restless) and somatic complains (e.g., sweating, trembling, heart pounding).
COVI Rating Scale total score is the sum of items 1 - 3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595231
|United States, Georgia|
|Atlanta, Georgia, United States, 30080|
|United States, Ohio|
|Midwest Clinical Research Center|
|Dayton, Ohio, United States, 45408|
|Study Chair:||Christpher Kenney, MD||Biotie Therapies Inc.|