PACEPro - Mood Management Pilot

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00416221
First received: December 22, 2006
Last updated: August 17, 2011
Last verified: August 2011

December 22, 2006
August 17, 2011
April 2006
Not Provided
  • 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 ] [ Designated as safety issue: No ]
  • Height and weight [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Waist & hip, circumference [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure and pulse [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Interview/Survey Measures [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Self report depressive symptoms [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Self-report of moderate and vigorous physical activity for seven days [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Self-report of TV viewing and recreational computer use for seven days [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Self-report on readiness to make changes in physical activity and mood management behaviors [ Time Frame: baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00416221 on ClinicalTrials.gov Archive Site
Not Provided
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Not Provided
 
PACEPro - Mood Management Pilot
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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Drug: Lexapro, an antidepressant medicine
  • Behavioral: Physical Activity
  • Behavioral: Mood Management Skills
  • Behavioral: Personalized support from a Family Nurse Practitioner
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2007
Not Provided

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
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00416221
LXP-MD-106, 2005-3889(UCSD Number)
Not Provided
Not Provided
Not Provided
Not Provided
University of California, San Diego
Forest Laboratories
Principal Investigator: Kevin Patrick, MD, MS UCSD
Study Director: Catherine Pearson-Bennett, MSN, RN UCSD
University of California, San Diego
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP