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Pharmacotherapy in Depression With Panic Spectrum

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline hydrochloride
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications Physically healthy, Female participants of childbearing potential must be practicing a medically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.

Sites / Locations

  • Western Psychiatric Insititue and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sertaline high dose titration

Sertaline low dose titration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Somatic Symptoms Scale (SSC)
Scale to evaluate somatic and panic like symptoms

Secondary Outcome Measures

Hamilton Rating Scale For Depression- 25 item (HRSD 25)
scale to evaluate depressive symptoms
Global Assessment of Functioning (GAF)
scale to evaluate ability to function

Full Information

First Posted
September 13, 2005
Last Updated
January 14, 2016
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00177996
Brief Title
Pharmacotherapy in Depression With Panic Spectrum
Official Title
Pharmacotherapy in Depression With Panic Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertaline high dose titration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sertaline low dose titration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sertraline hydrochloride
Other Intervention Name(s)
sertraline hydrochloride low versus high dose titration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Somatic Symptoms Scale (SSC)
Description
Scale to evaluate somatic and panic like symptoms
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale For Depression- 25 item (HRSD 25)
Description
scale to evaluate depressive symptoms
Time Frame
1 week
Title
Global Assessment of Functioning (GAF)
Description
scale to evaluate ability to function
Time Frame
past week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Fagiolini, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Insititue and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pharmacotherapy in Depression With Panic Spectrum

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