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

Primary Purpose

Phobia, Social, Panic Disorder, Agoraphobia

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Sertraline
Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phobia, Social focused on measuring Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MacAnxiety Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Sertraline

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2005
Last Updated
March 20, 2018
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00182533
Brief Title
Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Official Title
Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Study drug could not be re-supplied
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder
Keywords
Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sertraline
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
25 - 200 mg/day x 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
25 - 200 mg/day x 16 weeks
Primary Outcome Measure Information:
Title
Clinical Global Impression - Improvement ≤ 2
Time Frame
16 weeks
Title
Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Time Frame
16 weeks
Title
Sheehan Disability Scale
Time Frame
16 weeks
Title
Social Phobia Scale
Time Frame
16 weeks
Title
Brief Social Phobia Scale
Time Frame
16 weeks
Title
Penn State Worry Questionnaire
Time Frame
16 weeks
Title
Panic and Agoraphobia Scale
Time Frame
16 weeks
Title
Davidson Trauma Scale
Time Frame
16 weeks
Title
Social Anxiety Spectrum Self-Report (SHY-SR)
Time Frame
16 weeks
Title
Yale-Brown Obsessive Compulsive Scale
Time Frame
16 weeks
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Van Ameringen, MD, FRCPC
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada

12. IPD Sharing Statement

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

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