PACEPro - Mood Management Pilot - Full Text View

Sponsor:	University of California, San Diego
Collaborator:	Forest Laboratories
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00416221

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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 [ 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 ]

Enrollment:	40
Study Start Date:	April 2006
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

Additional Information:

PACEPro Website This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00416221 History of Changes
Other Study ID Numbers:	LXP-MD-106, 2005-3889(UCSD Number)
Study First Received:	December 22, 2006
Last Updated:	August 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Depression
Lexapro

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents

Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012