NCT00182533

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2017

Enrollment Period

15.5 years

First QC Date

September 14, 2005

Last Update Submit

March 20, 2018

Conditions

Phobia, SocialPanic DisorderAgoraphobiaObsessive-Compulsive DisorderAnxiety DisordersMajor Depressive Disorder

Keywords

Generalized social phobiaComorbid panic disorder with agoraphobiaComorbid obsessive compulsive disorderComorbid generalized anxiety disorderComorbid major depressive disorder/Dysthymia

Outcome Measures

Primary Outcomes (2)

  • Clinical Global Impression - Improvement ≤ 2

    16 weeks

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

    16 weeks

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Sertraline

Drug: Sertraline

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SertralineDRUG

25 - 200 mg/day x 16 weeks

Also known as: Zoloft
1
PlaceboDRUG

25 - 200 mg/day x 16 weeks

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Phobia, SocialPanic DisorderAgoraphobiaObsessive-Compulsive DisorderAnxiety DisordersDepressive Disorder, MajorDysthymic Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Phobic DisordersMental DisordersDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Michael Van Ameringen, MD, FRCPC

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 22, 2018

Record last verified: 2017-03

Locations

CA(1)