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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00282828 |
This study will compare the effectiveness of either adding clonazepam or placebo to standard treatment or switching to venlafaxine in treating generalized social anxiety disorder in individuals who have not responded to treatment with sertraline.
Condition | Intervention | Phase |
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Social Phobia |
Drug: Clonazepam Drug: Venlafaxine Drug: Sertraline Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Improving Outcomes in Pharmacotherapy of Social Phobia |
Estimated Enrollment: | 490 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B1: Experimental
Participants will take both sertraline and clonazepam
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Drug: Clonazepam
Participants take 0.5 to 3 mg per day of clonazepam for 12 weeks.
Drug: Sertraline
All participants take 50 to 200 mg per day of sertraline for the initial 10 weeks of treatment. Then some participants continue with sertraline and placebo or sertraline and clonazepam for 12 more weeks.
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B2: Experimental
Participants will take venlafaxine only
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Drug: Venlafaxine
Participants take 37.5 to 225 mg per day of venlafaxine for 12 weeks.
Drug: Sertraline
All participants take 50 to 200 mg per day of sertraline for the initial 10 weeks of treatment. Then some participants continue with sertraline and placebo or sertraline and clonazepam for 12 more weeks.
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B3: Experimental
Participants will take both sertraline and placebo
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Drug: Sertraline
All participants take 50 to 200 mg per day of sertraline for the initial 10 weeks of treatment. Then some participants continue with sertraline and placebo or sertraline and clonazepam for 12 more weeks.
Drug: Placebo
Participants take placebo with the sertraline for 12 weeks.
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Generalized social anxiety disorder (GSAD) is one of the most common psychiatric disorders, and often causes significant distress and dysfunction in affected individuals. Although currently available treatments for GSAD are effective, most individuals have residual symptoms after initial psychosocial or psychopharmacologic intervention. Further treatment is necessary for such individuals, but sufficient research has not been done to guide clinicians on what the safest and most effective next step may be. This study will compare the effectiveness of either combining clonazepam or placebo with sertraline or completely switching to venlafaxine in treating GSAD in individuals who have not responded to treatment with sertraline. This study will also examine predictors of treatment response, including factors such as age at disease onset, duration of illness, comorbidities, and genes that influence serotonin and catecholamine metabolism.
Participants in this double-blind study will first partake in an initial 10-week phase in which they will be treated with sertraline. Participants who do not respond to sertraline treatment will proceed to phase two of the study, in which they will be randomly assigned to one of three treatment groups. One group will receive both sertraline and clonazepam, another group will receive both sertraline and placebo, and the third group will receive only venlafaxine. All treatments will continue for 12 weeks. Sertraline and venlafaxine are both FDA-approved for the treatment of GSAD. Clonazepam is widely used for the treatment of anxiety, but is not FDA-approved for the treatment of GSAD. All participants will attend weekly study visits at Weeks 1, 2, 4, 6, 8, and 10. Participants who continue into phase two will attend weekly study visits at Weeks 11-14, 16, 18, 20, and 22. Symptom remission rates and post-treatment social phobia severity will be assessed at Week 20.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nannette N. Herlands, BA | 617-726-1570 | nherlands@partners.org |
United States, California | |
University of California San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Murray B. Stein, MD, MPH 858-534-6400 mstein@UCSD.Edu | |
Principal Investigator: Murray B. Stein, MD, MPH | |
Sub-Investigator: Denise A. Chavira, PhD | |
Sub-Investigator: Laura Campbell-Sills, PhD | |
Sub-Investigator: Scott C. Matthews, MD | |
Sub-Investigator: Ann Fleming, RN | |
United States, Massachusetts | |
Center for Anxiety and Traumatic Stress Disorders | Recruiting |
Boston, Massachusetts, United States, 02116 | |
Contact: Nannette N. Herlands, BA 617-736-1570 nherlands@partners.org | |
Principal Investigator: Mark H. Pollack, MD | |
Sub-Investigator: Naomi M. Simon, MD, MSC | |
Sub-Investigator: John J. Worthington, MD | |
Sub-Investigator: Elizabeth A. Hoge, MD | |
Sub-Investigator: David A. Schoenfeld, PhD | |
Sub-Investigator: David J. Dorer, PhD | |
Canada, Ontario | |
McMaster University Medical Centre Anxiety Disorders Clinic | Recruiting |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Contact: Michael Van Ameringen, MD, FRCPC 905-521-2100 ext 76181 vanamer@mcmaster.ca | |
Principal Investigator: Michael Van Ameringen, MD, FRCPC | |
Sub-Investigator: Catherine Mancini, MD, FRCPC | |
Sub-Investigator: Jonathan Oakman, PhD | |
Sub-Investigator: Beth Patterson, BScN, RN |
Principal Investigator: | Mark H. Pollack, MD | Massachusetts General Hospital |
Principal Investigator: | Murray B. Stein, MD, MPH | University of California San Deigo |
Principal Investigator: | Michael Van Ameringen, MD, FRCPC | Anxiety Disorders Clinic McMaster Univeristy Medical Centre |
Responsible Party: | Massachusetts General Hospital ( Mark Pollack, MD ) |
Study ID Numbers: | R01 MH70919, PA-01-123, DSIR 83-ATAS |
Study First Received: | January 25, 2006 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00282828 |
Health Authority: | United States: Federal Government; Canada: Health Canada |
Social Anxiety Disorder Pharmacotherapy Genetics Treatment Refractory |
Anxiety Disorders Mental Disorders Clonazepam Venlafaxine |
Sertraline Phobic Disorders Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Serotonin Agents Therapeutic Uses GABA Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Anticonvulsants Antidepressive Agents |