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

Sponsor:	McMaster University
Collaborator:	Pfizer
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182533

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 IV

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:

MedlinePlus related topics: Anxiety Depression Obsessive-Compulsive Disorder Panic Disorder Phobias

Drug Information available for: Sertraline hydrochloride Sertraline

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:	September 2011
Estimated Primary Completion Date:	August 2009 (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

905-521-2100 ext 76181

bpatter@mcmaster.ca

Locations

Canada, Ontario
McMaster University Medical Centre	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Diedre L Henne, CA 905-521-2100 ext 74595 henne@hhsc.ca
Principal Investigator: Michael Van Ameringen, MD, FRCPC
Sub-Investigator: Catherine Mancini, MD, FRCPC
Sub-Investigator: Steve Collins, MBChB, FRCPC
Sub-Investigator: Jonathan Oakman, PhD
Sub-Investigator: Beth Patterson, BScN, BEd

Sponsors and Collaborators

McMaster University

Pfizer

Investigators

Principal Investigator:

Michael Van Ameringen, MD, FRCPC

Hamilton Health Sciences Corporation

More Information

No publications provided

Responsible Party:	Dr. Michael Van Ameringen, Anxiety Disorder Clinic, McMaster University Medical Centre
ClinicalTrials.gov Identifier:	NCT00182533 History of Changes
Other Study ID Numbers:	02-195
Study First Received:	September 14, 2005
Last Updated:	September 1, 2010
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:

Agoraphobia
Anxiety Disorders
Depressive Disorder
Depression
Obsessive-Compulsive Disorder
Panic 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 February 09, 2012