PACEPro - Mood Management Pilot

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00416221
First received: December 22, 2006
Last updated: August 17, 2011
Last verified: August 2011
  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:


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:
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 April 17, 2014