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

Major Depressive Disorder Clinical Trial

Official title:

Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00182533
• Other study ID #: 02-195
• Status: Terminated
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: March 20, 2018
• Start date: July 2002
• Est. completion date: January 2018

Study information

• Verified date: March 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Phobic Disorders

Intervention

Drug:
• Sertraline
25 - 200 mg/day x 16 weeks
• Placebo
25 - 200 mg/day x 16 weeks

Locations

Country	Name	City	State
Canada	MacAnxiety Research Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression - Improvement = 2		16 weeks
Primary	Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)		16 weeks
Secondary	Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire		16 weeks
Secondary	Sheehan Disability Scale		16 weeks
Secondary	Social Phobia Scale		16 weeks
Secondary	Brief Social Phobia Scale		16 weeks
Secondary	Penn State Worry Questionnaire		16 weeks
Secondary	Panic and Agoraphobia Scale		16 weeks
Secondary	Davidson Trauma Scale		16 weeks
Secondary	Social Anxiety Spectrum Self-Report (SHY-SR)		16 weeks
Secondary	Yale-Brown Obsessive Compulsive Scale		16 weeks
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)		16 weeks