Pharmacotherapy in Depression With Panic Spectrum

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Fagiolini, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177996
First received: September 13, 2005
Last updated: January 14, 2016
Last verified: January 2016
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Pharmacotherapy in Depression With Panic Spectrum

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Somatic Symptoms Scale (SSC) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Scale to evaluate somatic and panic like symptoms


Secondary Outcome Measures:
  • Hamilton Rating Scale For Depression- 25 item (HRSD 25) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    scale to evaluate depressive symptoms

  • Global Assessment of Functioning (GAF) [ Time Frame: past week ] [ Designated as safety issue: No ]
    scale to evaluate ability to function


Enrollment: 30
Study Start Date: October 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sertaline high dose titration
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline high dose titration) are consistent with recommended FDA guidelines.
Drug: sertraline hydrochloride
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
Other Name: sertraline hydrochloride low versus high dose titration
Active Comparator: Sertaline low dose titration
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline low dose titration) are consistent with recommended FDA guidelines.
Drug: sertraline hydrochloride
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
Other Name: sertraline hydrochloride low versus high dose titration

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Andrea Fagiolini, M.D. University of Pittsburgh
  More Information

Responsible Party: Andrea Fagiolini, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177996     History of Changes
Other Study ID Numbers: 010403 
Study First Received: September 13, 2005
Last Updated: January 14, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Pittsburgh:
depression
anxiety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016