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OpenTrials
Completed

NCT Number: NCT00177996

Pharmacotherapy in Depression With Panic Spectrum

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Western Psychiatric Insititue and Clinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications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.

Treatment and study plan

sertraline hydrochloride

Drug

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 names: sertraline hydrochloride low versus high dose titration

Primary outcomes

  1. Somatic Symptoms Scale (SSC)

    Time frame: 1 week

    Scale to evaluate somatic and panic like symptoms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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