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

Phobia, Social research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Phobia, Social

Panic Disorder

Agoraphobia

Obsessive-Compulsive Disorder

Anxiety Disorders

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sertraline25 - 200 mg/day x 16 weeks

Drug:Placebo25 - 200 mg/day x 16 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Sertraline

2Placebo

Study Status

Active, not recruiting

Start Date: July 2002

Completed Date: March 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Clinical Global Impression - Improvement ≤ 2

Secondary Outcome: Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Michael Van Ameringen, MD, FRCPC

Lead Sponsor: Hamilton Health Sciences Corporation

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT00182533

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