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CompletedNCT00416221Updated Aug 18, 2011

PACEPro - Mood Management Pilot

An interventional study of Lexapro, an antidepressant medicine and Physical Activity in Depression, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-18.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Depression

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Keywords

  • Depression
  • Lexapro
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • DrugLexapro, an antidepressant medicine
  • BehavioralPhysical Activity
  • BehavioralMood Management Skills
  • BehavioralPersonalized support from a Family Nurse Practitioner
06

What researchers measure

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

07

Study locations

1 site
  • UCSD Professional Building
    La Jolla, California 92037, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00416221
Lead sponsor
University of California, San Diego
Collaborators
Forest Laboratories
First posted
Dec 27, 2006
Start date
Apr 2006
Completion
Jan 2007
Last update
Aug 18, 2011

Study contacts

Kevin Patrick, MD, MS
principal investigator · UCSD
Catherine Pearson-Bennett, MSN, RN
study director · UCSD
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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