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Pharmacotherapy in Depression With Panic Spectrum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00177996
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Andrea Fagiolini, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Drug: sertraline hydrochloride Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pharmacotherapy in Depression With Panic Spectrum
Study Start Date : October 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Somatic Symptoms Scale (SSC) [ Time Frame: 1 week ]
    Scale to evaluate somatic and panic like symptoms


Secondary Outcome Measures :
  1. Hamilton Rating Scale For Depression- 25 item (HRSD 25) [ Time Frame: 1 week ]
    scale to evaluate depressive symptoms

  2. Global Assessment of Functioning (GAF) [ Time Frame: past week ]
    scale to evaluate ability to function



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177996


Locations
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United States, Pennsylvania
Western Psychiatric Insititue and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Andrea Fagiolini, M.D. University of Pittsburgh
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Responsible Party: Andrea Fagiolini, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177996    
Other Study ID Numbers: 010403
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andrea Fagiolini, University of Pittsburgh:
depression
anxiety
Additional relevant MeSH terms:
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Depression
Depressive Disorder
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