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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Phobia, Social Panic Disorder Agoraphobia Obsessive-Compulsive Disorder Anxiety Disorders Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Sertraline

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

25 - 200 mg/day x 16 weeks

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

25 - 200 mg/day x 16 weeks

Interventions

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Sertraline

25 - 200 mg/day x 16 weeks

Intervention Type DRUG

Placebo

25 - 200 mg/day x 16 weeks

Intervention Type DRUG

Other Intervention Names

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Zoloft

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No