PACEPro - Mood Management Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416221
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : August 18, 2011
Forest Laboratories
Information provided by:
University of California, San Diego

Brief 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

Condition or disease Intervention/treatment Phase
Depression Drug: Lexapro, an antidepressant medicine Behavioral: Physical Activity Behavioral: Mood Management Skills Behavioral: Personalized support from a Family Nurse Practitioner Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
Study Start Date : April 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.
  2. Physiological Measures [ Time Frame: baseline, 6 weeks, 12 weeks ]
  3. Height and weight [ Time Frame: baseline, 6 weeks, 12 weeks ]
  4. Waist & hip, circumference [ Time Frame: baseline, 6 weeks, 12 weeks ]
  5. Blood pressure and pulse [ Time Frame: baseline, 6 weeks, 12 weeks ]
  6. 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 ]
  7. Interview/Survey Measures [ Time Frame: baseline, 6 weeks, 12 weeks ]
  8. Self report depressive symptoms [ Time Frame: baseline, 6 weeks, 12 weeks ]
  9. Self-report of moderate and vigorous physical activity for seven days [ Time Frame: baseline, 6 weeks, 12 weeks ]
  10. Self-report of TV viewing and recreational computer use for seven days [ Time Frame: baseline, 6 weeks, 12 weeks ]
  11. Self-report on readiness to make changes in physical activity and mood management behaviors [ Time Frame: baseline, 6 weeks, 12 weeks ]
  12. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416221

United States, California
UCSD Professional Building
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Forest Laboratories
Principal Investigator: Kevin Patrick, MD, MS UCSD
Study Director: Catherine Pearson-Bennett, MSN, RN UCSD Identifier: NCT00416221     History of Changes
Other Study ID Numbers: LXP-MD-106
2005-3889(UCSD Number)
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by University of California, San Diego:

Additional relevant MeSH terms:
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents