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Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
This study is currently recruiting participants.
Study NCT00182533   Information provided by McMaster University
First Received: September 14, 2005   Last Updated: September 17, 2009   History of Changes

September 14, 2005
September 17, 2009
July 2002
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Clincal Global Impression -Improvement ≤ 2
  • Liebowitz Social Anxiety Scale (mean change from baseline)
Complete list of historical versions of study NCT00182533 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • SHY-SR
  • Yale-Brown Obsessive Compulsive Scale
  • Montgomery Asberg Depression Rating Scale
 
Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
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.

 
Phase IV
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment
  • Phobia, Social
  • Panic Disorder
  • Agoraphobia
  • Obsessive-Compulsive Disorder
  • Anxiety Disorders
  • Major Depressive Disorder
  • Drug: Sertraline
    25 - 200 mg/day x 16 weeks
    Other Name: Zoloft
  • Drug: Placebo
    25 - 200 mg/day x 16 weeks
  • 1: Experimental
    Sertraline
    Intervention: Drug: Sertraline
  • 2: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
170
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Beth Patterson, BScN, BEd 905-521-2100 ext 76181 bpatter@mcmaster.ca
Canada
 
NCT00182533
Dr. Michael Van Ameringen, Anxiety Disorder Clinic, McMaster University Medical Centre
02-195
McMaster University
Pfizer
Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences
McMaster University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP