Pharmacotherapy in Depression With Panic Spectrum

Major Depression Clinical Trial

Official title:

Pharmacotherapy in Depression With Panic Spectrum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177996
• Other study ID #: 010403
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 14, 2016
• Start date: October 2001
• Est. completion date: January 2007

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Western Psychiatric Insititue and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Somatic Symptoms Scale (SSC)	Scale to evaluate somatic and panic like symptoms	1 week	No
Secondary	Hamilton Rating Scale For Depression- 25 item (HRSD 25)	scale to evaluate depressive symptoms	1 week	No
Secondary	Global Assessment of Functioning (GAF)	scale to evaluate ability to function	past week	No