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

NCT00182533

Last updated date
Study Location
MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B7, Canada
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Social Phobia, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Social Phobia, Panic Disorder, Agoraphobia, Obsessive-Compulsive Disorder, Anxiety Disorders, Major Depressive DisorderSertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
NCT00182533
  1. Hamilton, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Official Title  ICMJE Sertraline in the Treatment of Generalized Social Phobia With Comorbidity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Phobia, Social
  • Panic Disorder
  • Agoraphobia
  • Obsessive-Compulsive Disorder
  • Anxiety Disorders
  • Major Depressive Disorder
Intervention  ICMJE
  • Drug: Sertraline
    25 - 200 mg/day x 16 weeks
    Other Name: Zoloft
  • Drug: Placebo
    25 - 200 mg/day x 16 weeks
Study Arms  ICMJE
  • Experimental: 1
    Sertraline
    Intervention: Drug: Sertraline
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 14, 2005)
170
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00182533
Other Study ID Numbers  ICMJE 02-195
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University ( Hamilton Health Sciences Corporation )
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Michael Van Ameringen, MD, FRCPCHamilton Health Sciences Corporation
PRS Account McMaster University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP