Depression
Conditions
Keywords
Depression, Lexapro
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
Interventions
DRUGLexapro, an antidepressant medicine
BEHAVIORALPhysical Activity
BEHAVIORALMood Management Skills
BEHAVIORALPersonalized support from a Family Nurse Practitioner
Sponsors
Forest Laboratories
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed