Clinical trial NCT00182533: Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Official title: Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Phobia, Social
Panic Disorder
Agoraphobia
Obsessive-Compulsive Disorder
Anxiety Disorders
Major Depressive Disorder
Keywords: Generalized social phobia
Comorbid panic disorder with agoraphobia
Comorbid obsessive compulsive disorder
Comorbid generalized anxiety disorder
Comorbid major depressive disorder/Dysthymia
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-16
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical Global Impression - Improvement ≤ 2
timeFrame: 16 weeks
measure: Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
timeFrame: 16 weeks
Secondary outcomes:
measure: Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
timeFrame: 16 weeks
measure: Sheehan Disability Scale
timeFrame: 16 weeks
measure: Social Phobia Scale
timeFrame: 16 weeks
measure: Brief Social Phobia Scale
timeFrame: 16 weeks
measure: Penn State Worry Questionnaire
timeFrame: 16 weeks
measure: Panic and Agoraphobia Scale
timeFrame: 16 weeks
measure: Davidson Trauma Scale
timeFrame: 16 weeks
measure: Social Anxiety Spectrum Self-Report (SHY-SR)
timeFrame: 16 weeks
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: 16 weeks
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: MacAnxiety Research Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Michael Van Ameringen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: