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

Phase 4

Terminated

• Conditions: Phobia, Social; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Major Depressive Disorder; Anxiety Disorders
• Interventions: Drug: Placebo; Drug: Sertraline

• Registration Number: NCT00182533
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Status Verified: 2017-03
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Sertraline	Sertraline

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement ≤ 2	16 weeks
Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)	16 weeks

Secondary Outcome Measures

Name	Time	Method
Social Phobia Scale	16 weeks
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire	16 weeks
Sheehan Disability 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

Trial Locations

Locations (1)

MacAnxiety Research Centre; 🇨🇦 Hamilton, Ontario, Canada