Back to resultsPACEPro - Mood Management Pilot
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lexapro, an antidepressant medicine
Physical Activity
Mood Management Skills
Personalized support from a Family Nurse Practitioner
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Lexapro
Eligibility 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
Sites / Locations
- UCSD Professional Building
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00416221
First Posted
December 22, 2006
Last Updated
August 17, 2011
Sponsor
University of California, San Diego
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00416221
Brief Title
PACEPro - Mood Management Pilot
Official Title
Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Diego
Collaborators
Forest Laboratories
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Lexapro
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lexapro, an antidepressant medicine
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Type
Behavioral
Intervention Name(s)
Mood Management Skills
Intervention Type
Behavioral
Intervention Name(s)
Personalized support from a Family Nurse Practitioner
Primary Outcome Measure Information:
Title
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.
Title
Physiological Measures
Time Frame
baseline, 6 weeks, 12 weeks
Title
Height and weight
Time Frame
baseline, 6 weeks, 12 weeks
Title
Waist & hip, circumference
Time Frame
baseline, 6 weeks, 12 weeks
Title
Blood pressure and pulse
Time Frame
baseline, 6 weeks, 12 weeks
Title
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
Title
Interview/Survey Measures
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self report depressive symptoms
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self-report of moderate and vigorous physical activity for seven days
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self-report of TV viewing and recreational computer use for seven days
Time Frame
baseline, 6 weeks, 12 weeks
Title
Self-report on readiness to make changes in physical activity and mood management behaviors
Time Frame
baseline, 6 weeks, 12 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Patrick, MD, MS
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Pearson-Bennett, MSN, RN
Organizational Affiliation
UCSD
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Professional Building
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PACEPro - Mood Management Pilot
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