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Completed

NCT Number: NCT00416221

PACEPro - Mood Management Pilot

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Professional Building

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lexapro, an antidepressant medicine

Drug

Physical activity

Behavioral

Mood Management Skills

Behavioral

Personalized support from a Family Nurse Practitioner

Behavioral

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 27, 2006
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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