Pharmacotherapy in Depression With Panic Spectrum
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborator:
Mental Health Intervention Research Center (MHIRC)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177996
First received: September 13, 2005
Last updated: April 17, 2007
Last verified: April 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Major Depression |
Drug: sertraline hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Pharmacotherapy in Depression With Panic Spectrum |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Somatic Symptoms Scale (SSC)
Secondary Outcome Measures:
- Hamilton Rating Scale For Depression- 25 item (HRSD 25)
- Global Assessment of Functioning (GAF)
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2001 |
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
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177996
Locations
| United States, Pennsylvania | |
| Western Psychiatric Insititue and Clinic | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
University of Pittsburgh
Mental Health Intervention Research Center (MHIRC)
Investigators
| Principal Investigator: | Andrea Fagiolini, M.D. | University of Pittsburgh |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00177996 History of Changes |
| Other Study ID Numbers: | 010403 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 17, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pittsburgh:
|
depression anxiety |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013