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Pharmacotherapy in Depression With Panic Spectrum
This study has been completed.
Sponsors and Collaborators: University of Pittsburgh
Mental Health Intervention Research Center (MHIRC)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177996
  Purpose

This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.


Condition Intervention Phase
Major Depression
Drug: sertraline hydrochloride
Phase IV

MedlinePlus related topics: Depression
Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Pharmacotherapy in Depression With Panic Spectrum

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Somatic Symptoms Scale (SSC)

Secondary Outcome Measures:
  • Hamilton Rating Scale For Depression- 25 item (HRSD 25)
  • Global Assessment of Functioning (GAF)

Estimated Enrollment: 30
Study Start Date: October 2001
Detailed Description:

Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.

Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ages 18-60;
  • Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
  • Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
  • Physically healthy,
  • Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;

Exclusion Criteria:

  • Females who are pregnant or breast-feeding;
  • History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
  • History of hypersensitivity to or current use of sertraline;
  • Unstable or untreated medical conditions,
  • Participants who do not wish to discontinue current, ineffective antidepressant treatment;
  • Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
  • Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177996

Locations
United States, Pennsylvania
Western Psychiatric Insititue and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Mental Health Intervention Research Center (MHIRC)
Investigators
Principal Investigator: Andrea Fagiolini, M.D. University of Pittsburgh
  More Information

Study ID Numbers: 010403
Study First Received: September 13, 2005
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00177996  
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
depression
anxiety

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009