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

Hamilton Health Sciences (HHS)

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Placebo; Drug: Sertraline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00182533

02-195

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Sertraline

Treatment:

Drug: Sertraline

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo