PACEPro - Mood Management Pilot
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Lexapro, an antidepressant medicine (Drug); Physical Activity (Behavioral); Mood Management Skills (Behavioral); Personalized support from a Family Nurse Practitioner (Behavioral)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Kevin Patrick, MD, MS, Principal Investigator, Affiliation: UCSD
Catherine Pearson-Bennett, MSN, RN, Study Director, Affiliation: UCSD
Summary
Researchers at the University of California at San Diego (UCSD) are conducting a 12-week
study to test the PACEPRO program. This program is designed to reduce depression by
providing:
Lexapro, an antidepressant medicine…Learn More Physical activity information and pedometer
Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse
Practitioner
Clinical Details
Official title: Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Measurement visits will be conducted at the PACE office. The specific activities to be conducted at the baseline, 6 and 12 week assessment visits are listed below.Physiological Measures Height and weight Waist & hip, circumference Blood pressure and pulse Physical activity level measured by wearing a monitor around the waist for 3 days (at baseline and 12 weeks only) Interview/Survey Measures Self report depressive symptoms Self-report of moderate and vigorous physical activity for seven days Self-report of TV viewing and recreational computer use for seven days Self-report on readiness to make changes in physical activity and mood management behaviors Personal assessment of factors related to behavior change including: self-efficacy, social support, barriers to change, and use of behavior change skills, and the environment
Eligibility
Minimum age: 25 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have been diagnosed with mild to moderate depression
- Are willing to take the antidepressant Lexapro
- Can access and use Email and the Internet
- Are willing and able to be physically active
- Access to a primary care physician
Exclusion Criteria:
Subjects will be excluded from participation for the following reasons:
- Pregnancy or breastfeeding
- Narrow angle glaucoma
- Any uncontrolled medical condition or any medical condition which would represent a
contraindication to Escitalopram Oxalate Lexapro® pharmacotherapy. Any concomitant
non-psychotropic medications that the physician determines are a contraindication to
Escitalopram Oxalate Lexapro® pharmacotherapy Bipolar disorder, or any psychotic or
organic mental disorder or dementia
- History of intolerance or allergy to Lexapro, or of prior failed treatment for
depression with Lexapro
- Current substance abuse or dependency
- Current active suicidal ideation
- Current use of herbal psychoactive treatments such as St. John’s Wort
- Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization
(4 weeks in the case of fluoxetine) or at any point after
- Receipt of formal psychotherapy concurrently
- Inability, in the investigator’s opinion, to comply with study procedures or
assessments
- Inability to exercise
Locations and Contacts
UCSD Professional Building, La Jolla, California 92037, United States
Additional Information
PACEPro Website
Starting date: April 2006
Ending date: January 2007
Last updated: December 26, 2006
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