Clinical trial NCT00416221: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lexapro
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2006-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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.
measure: Physiological Measures
timeFrame: baseline, 6 weeks, 12 weeks
measure: Height and weight
timeFrame: baseline, 6 weeks, 12 weeks
measure: Waist & hip, circumference
timeFrame: baseline, 6 weeks, 12 weeks
measure: Blood pressure and pulse
timeFrame: baseline, 6 weeks, 12 weeks
measure: Physical activity level measured by wearing a monitor around the waist for 3 days (at baseline and 12 weeks only)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Interview/Survey Measures
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self report depressive symptoms
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self-report of moderate and vigorous physical activity for seven days
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self-report of TV viewing and recreational computer use for seven days
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self-report on readiness to make changes in physical activity and mood management behaviors
timeFrame: baseline, 6 weeks, 12 weeks
measure: 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
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Professional Building
state: California
Study officials:
affiliation: UCSD
name: Kevin Patrick, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Catherine Pearson-Bennett, MSN, RN
role: STUDY_DIRECTOR
References: