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

March 20, 2018 updated by: Hamilton Health Sciences Corporation

Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1B7
        • MacAnxiety Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
25 - 200 mg/day x 16 weeks
Experimental: 1
Sertraline
Drug: Sertraline
25 - 200 mg/day x 16 weeks
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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