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

This study is currently recruiting participants.
Verified March 2013 by McMaster University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M. Van Ameringen, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00182533
First received: September 14, 2005
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Phobia, Social
Panic Disorder
Agoraphobia
Obsessive-Compulsive Disorder
Anxiety Disorders
Major Depressive Disorder
 Drug: Sertraline
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Social Phobia Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Brief Social Phobia Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Panic and Agoraphobia Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Davidson Trauma Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Social Anxiety Spectrum Self-Report (SHY-SR) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: July 2002
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sertraline
 Drug: Sertraline
25 - 200 mg/day x 16 weeks
Other Name: Zoloft
Placebo Comparator: 2
Placebo
 Drug: Placebo
25 - 200 mg/day x 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182533

Contacts
Contact: Beth Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca

Locations
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd     905-921-7644     bpatter@mcmaster.ca    
Principal Investigator: Michael Van Ameringen, MD, FRCPC            
Sub-Investigator: Catherine Mancini, MD, FRCPC            
Sub-Investigator: Steve Collins, MBChB, FRCPC            
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Pfizer
Investigators
Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: M. Van Ameringen, Professor, Department of Psychiatry and Behavioural Neurosciences, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00182533     History of Changes
Other Study ID Numbers: 02-195
Study First Received: September 14, 2005
Last Updated: March 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Generalized social phobia
Comorbid panic disorder with agoraphobia
Comorbid obsessive compulsive disorder
Comorbid generalized anxiety disorder
Comorbid major depressive disorder/Dysthymia

Additional relevant MeSH terms:
Panic Disorder
Agoraphobia
Anxiety Disorders
Depressive Disorder
Depression
Obsessive-Compulsive Disorder
Phobic Disorders
Depressive Disorder, Major
Mental Disorders
Mood Disorders
Behavioral Symptoms
Sertraline
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013