PACEPro - Mood Management Pilot

August 17, 2011 updated by: University of California, San Diego

Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Professional Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Height and weight
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Waist & hip, circumference
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Blood pressure and pulse
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Physical activity level measured by wearing a monitor around the waist for 3 days (at baseline and 12 weeks only)
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Interview/Survey Measures
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Self report depressive symptoms
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Self-report of moderate and vigorous physical activity for seven days
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Self-report of TV viewing and recreational computer use for seven days
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
Self-report on readiness to make changes in physical activity and mood management behaviors
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks
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
Time Frame: baseline, 6 weeks, 12 weeks
baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Forest Laboratories

Investigators

  • Study Director: Catherine Pearson-Bennett, MSN, RN, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 26, 2006

First Posted (ESTIMATE)

December 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LXP-MD-106
  • 2005-3889(UCSD Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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