TerminatedPhase 4

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

Stopped: Study drug could not be re-supplied

Canada170 participantsStarted 2002-07

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical Global Impression - Improvement ≤ 2

Timeframe: 16 weeks

Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)

Timeframe: 16 weeks

Trial details

NCT IDNCT00182533

SponsorHamilton Health Sciences Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01