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

Condition(s) targeted: Phobia, Social; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Anxiety Disorders; Major Depressive Disorder

Intervention: Sertraline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
Michael Van Ameringen, MD, FRCPC, Principal Investigator, Affiliation: Hamilton Health Sciences

Overall contact:
Beth Patterson, BScN, BEd, Phone: 905-521-2100, Ext: 76181, Email: bpatter@mcmaster.ca

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.

Official title: Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Clinical Global Impression - Improvement ≤ 2

Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)

Secondary outcome:

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

Social Anxiety Spectrum Self-Report (SHY-SR)

Yale-Brown Obsessive Compulsive Scale

Montgomery-Asberg Depression Rating Scale (MADRS)

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Beth Patterson, BScN, BEd, Phone: 905-521-2100, Ext: 76181, Email: bpatter@mcmaster.ca

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

Starting date: July 2002
Ending date: September 2009
Last updated: September 17, 2009