PACEPro - Mood Management Pilot
This study has been completed.
Sponsor:
University of California, San Diego
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
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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 May 22, 2013