Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders

Study Overview
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Brief Summary
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Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.

Official Title
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Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

Conditions
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Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder

Intervention / Treatment
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* Drug: Sertraline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders: panic disorder with agoraphobia obsessive compulsive disorder major depressive disorder generalized anxiety disorder Score on LSAS > 50 Score on MADRS < 25 Exclusion Criteria: Any other primary AXIS-I diagnosis Criteria for alcohol/substance abuse/dependence History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder A comorbid Axis II cluster A personality disorder Current increased risk of concomitant suicide Allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline Participation in any clinical trial 30 days prior to entering the study Unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks Hx of seizures Thyroid problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sertraline | Drug: Sertraline<br>* 25 - 200 mg/day x 16 weeks<br>* Other names: Zoloft;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 25 - 200 mg/day x 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement ≤ 2 |  | 16 weeks | 
| Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire |  | 16 weeks | 
| Sheehan Disability Scale |  | 16 weeks | 
| Social Phobia Scale |  | 16 weeks | 
| Brief Social Phobia Scale |  | 16 weeks | 
| Penn State Worry Questionnaire |  | 16 weeks | 
| Panic and Agoraphobia Scale |  | 16 weeks | 
| Davidson Trauma Scale |  | 16 weeks | 
| Social Anxiety Spectrum Self-Report (SHY-SR) |  | 16 weeks | 
| Yale-Brown Obsessive Compulsive Scale |  | 16 weeks | 
| Montgomery-Asberg Depression Rating Scale (MADRS) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia