Pharmacotherapy in Depression With Panic Spectrum

Study Overview
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Brief Summary
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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
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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

Official Title
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Pharmacotherapy in Depression With Panic Spectrum

Conditions
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Major Depression

Intervention / Treatment
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* Drug: sertraline hydrochloride


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with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications Physically healthy, Female participants of childbearing potential must be practicing a medically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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertaline high dose titration<br>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<br>* 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.<br>* Other names: sertraline hydrochloride low versus high dose titration;|
| Active Comparator: Sertaline low dose titration<br>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<br>* 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.<br>* Other names: sertraline hydrochloride low versus high dose titration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatic Symptoms Scale (SSC) | Scale to evaluate somatic and panic like symptoms | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale For Depression- 25 item (HRSD 25) | scale to evaluate depressive symptoms | 1 week | 
| Global Assessment of Functioning (GAF) | scale to evaluate ability to function | past week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety