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PACEPro - Mood Management Pilot
This study is ongoing, but not recruiting participants.
First Received: December 22, 2006   Last Updated: December 26, 2006   History of Changes
Sponsor: University of California, San Diego
Collaborator: Forest Laboratories
Information provided by: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00416221
  Purpose

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


Condition Intervention
Depression
Drug: Lexapro, an antidepressant medicine
Behavioral: Physical Activity
Behavioral: Mood Management Skills
Behavioral: Personalized support from a Family Nurse Practitioner

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416221

Locations
United States, California
UCSD Professional Building
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Forest Laboratories
Investigators
Principal Investigator: Kevin Patrick, MD, MS UCSD
Study Director: Catherine Pearson-Bennett, MSN, RN UCSD
  More Information

Additional Information:
No publications provided

Study ID Numbers: LXP-MD-106, 2005-3889(UCSD Number)
Study First Received: December 22, 2006
Last Updated: December 26, 2006
ClinicalTrials.gov Identifier: NCT00416221     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Depression
Lexapro

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 22, 2009