Agoraphobia, Anxiety Disorders, Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Phobia, Social
Conditions
Keywords
Generalized social phobia, Comorbid panic disorder with agoraphobia, Comorbid obsessive compulsive disorder, Comorbid generalized anxiety disorder, Comorbid major depressive disorder/Dysthymia
Brief 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.
Interventions
DRUGSertraline
25 - 200 mg/day x 16 weeks
DRUGPlacebo
25 - 200 mg/day x 16 weeks
Sponsors
Pfizer
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression - Improvement ≤ 2 | 16 weeks |
| Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline) | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire | 16 weeks |
| Sheehan Disability Scale | 16 weeks |
| Social Phobia Scale | 16 weeks |
| Brief Social Phobia Scale | 16 weeks |
| Penn State Worry Questionnaire | 16 weeks |
| Panic and Agoraphobia Scale | 16 weeks |
| Davidson Trauma Scale | 16 weeks |
| Social Anxiety Spectrum Self-Report (SHY-SR) | 16 weeks |
| Yale-Brown Obsessive Compulsive Scale | 16 weeks |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 16 weeks |
Countries
Canada
Outcome results
None listed