PACEPro - Mood Management Pilot - Full Text View

Purpose

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

Condition	Intervention
Depression	Drug: Lexapro, an antidepressant medicine Behavioral: Physical Activity Behavioral: Mood Management Skills Behavioral: Personalized support from a Family Nurse Practitioner

MedlinePlus related topics:

Antidepressants Depression

Drug Information available for:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)

Further study details as provided by University of California, San Diego:

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

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416221

Locations


United States, California
	UCSD Professional Building
	La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Forest Laboratories

Investigators


Principal Investigator:	Kevin Patrick, MD, MS	UCSD

Study Director:	Catherine Pearson-Bennett, MSN, RN	UCSD

More Information

PACEPro Website This link exits the ClinicalTrials.gov site

Study ID Numbers:	LXP-MD-106, 2005-3889(UCSD Number)
First Received:	December 22, 2006
Last Updated:	December 26, 2006
ClinicalTrials.gov Identifier:	NCT00416221
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Depression

Lexapro

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Dexetimide

Depressive Disorder

Citalopram

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Serotonin Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	University of California, San Diego Forest Laboratories
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00416221