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

This study is ongoing, but not recruiting participants.
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 21, 2017
Last verified: March 2017
  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
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

Resource links provided by NLM:


Further study details as provided by M. Van Ameringen, Hamilton Health Sciences Corporation:

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

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

Estimated Enrollment: 170
Study Start Date: July 2002
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (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   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 21, 2017

Keywords provided by M. Van Ameringen, 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
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

ClinicalTrials.gov processed this record on September 20, 2017