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

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ClinicalTrials.gov Identifier: NCT00182533
Recruitment Status : Terminated (Study drug could not be re-supplied)
First Posted : September 16, 2005
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
McMaster University ( 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
Study Start Date : July 2002
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire [ Time Frame: 16 weeks ]
  2. Sheehan Disability Scale [ Time Frame: 16 weeks ]
  3. Social Phobia Scale [ Time Frame: 16 weeks ]
  4. Brief Social Phobia Scale [ Time Frame: 16 weeks ]
  5. Penn State Worry Questionnaire [ Time Frame: 16 weeks ]
  6. Panic and Agoraphobia Scale [ Time Frame: 16 weeks ]
  7. Davidson Trauma Scale [ Time Frame: 16 weeks ]
  8. Social Anxiety Spectrum Self-Report (SHY-SR) [ Time Frame: 16 weeks ]
  9. Yale-Brown Obsessive Compulsive Scale [ Time Frame: 16 weeks ]
  10. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182533


Locations
Canada, Ontario
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Pfizer
Investigators
Principal Investigator: Michael Van Ameringen, MD, FRCPC Hamilton Health Sciences Corporation

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00182533     History of Changes
Other Study ID Numbers: 02-195
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2017

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
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:
Disease
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Phobic Disorders
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms
Personality Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs