PACEPro - Mood Management Pilot

NCT00416221 | Completed

• 2 other identifiers: LXP-MD-1062005-3889(UCSD Number)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

Depression; Lexapro

Outcome Measures

Primary Outcomes (12)

• 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

  baseline, 6 weeks, 12 weeks

• Height and weight

  baseline, 6 weeks, 12 weeks

• Waist & hip, circumference

  baseline, 6 weeks, 12 weeks

• Blood pressure and pulse

  baseline, 6 weeks, 12 weeks

• Physical activity level measured by wearing a monitor around the waist for 3 days (at baseline and 12 weeks only)

  baseline, 6 weeks, 12 weeks

• Interview/Survey Measures

  baseline, 6 weeks, 12 weeks

• Self report depressive symptoms

  baseline, 6 weeks, 12 weeks

• Self-report of moderate and vigorous physical activity for seven days

  baseline, 6 weeks, 12 weeks

• Self-report of TV viewing and recreational computer use for seven days

  baseline, 6 weeks, 12 weeks

• Self-report on readiness to make changes in physical activity and mood management behaviors

  baseline, 6 weeks, 12 weeks

• 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

  baseline, 6 weeks, 12 weeks

Interventions

Lexapro, an antidepressant medicine DRUG

Physical Activity BEHAVIORAL

Mood Management Skills BEHAVIORAL

Personalized support from a Family Nurse Practitioner BEHAVIORAL

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Forest Laboratories: collaborator

Study Sites (1)

UCSD Professional Building

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram; Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kevin Patrick, MD, MS

  UCSD

  PRINCIPAL INVESTIGATOR

• Catherine Pearson-Bennett, MSN, RN

  UCSD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 27, 2006
• Study Start: April 1, 2006
• Study Completion: January 1, 2007
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

US (1)