DepressionNCT00416221
PACEPro - Mood Management Pilot
A study testing Lexapro, an antidepressant medicine, Physical Activity and Mood Management Skills in people with Depression, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Lexapro, an antidepressant medicine, Physical Activity and Mood Management Skills
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Professional Building
La Jolla, California, 92037
About this study
Official title: Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
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
- Conditions
- Depression
- Being tested
- Lexapro, an antidepressant medicine, Physical Activity, Mood Management Skills, Personalized support from a Family Nurse Practitioner
- Keywords
- Depression, Lexapro
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lexapro, an antidepressant medicineDrug
Physical ActivityBehavioural
Mood Management SkillsBehavioural
Personalized support from a Family Nurse PractitionerBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 weeks, 12 weeks
Height and weight
Measured: baseline, 6 weeks, 12 weeks
Waist & hip, circumference
Measured: baseline, 6 weeks, 12 weeks
Blood pressure and pulse
Measured: 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)
Measured: baseline, 6 weeks, 12 weeks
Interview/Survey Measures
Measured: baseline, 6 weeks, 12 weeks
Self report depressive symptoms
Measured: baseline, 6 weeks, 12 weeks
Self-report of moderate and vigorous physical activity for seven days
Measured: baseline, 6 weeks, 12 weeks
Self-report of TV viewing and recreational computer use for seven days
Measured: baseline, 6 weeks, 12 weeks
Self-report on readiness to make changes in physical activity and mood management behaviors
Measured: 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
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startApr 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Kevin Patrick, MD, MS, Principal investigator, UCSDCatherine Pearson-Bennett, MSN, RN, Study director, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416221
- Sponsor's protocol ID
- LXP-MD-106
- Other IDs
- 2005-3889(UCSD Number)
- Status last verified
- Aug 2011
- First submitted
- 22 Dec 2006
- Last updated
- 18 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro)
- ClinicalTrials.gov ID
- NCT00416221
- Acronym / sponsor ID
- LXP-MD-106
- Conditions
- Depression
- Keywords
- Depression, Lexapro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lexapro, an antidepressant medicine | Drug | – |
| Physical Activity | Behavioural | – |
| Mood Management Skills | Behavioural | – |
| Personalized support from a Family Nurse Practitioner | Behavioural | – |
Primary outcome
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
Height and weight
Time frame: baseline, 6 weeks, 12 weeks
Waist & hip, circumference
Time frame: baseline, 6 weeks, 12 weeks
Blood pressure and pulse
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks
Interview/Survey Measures
Time frame: baseline, 6 weeks, 12 weeks
Self report depressive symptoms
Time frame: baseline, 6 weeks, 12 weeks
Self-report of moderate and vigorous physical activity for seven days
Time frame: baseline, 6 weeks, 12 weeks
Self-report of TV viewing and recreational computer use for seven days
Time frame: baseline, 6 weeks, 12 weeks
Self-report on readiness to make changes in physical activity and mood management behaviors
Time frame: 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
Time frame: baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Patrick, MD, MS principal investigator
UCSD
Catherine Pearson-Bennett, MSN, RN study director
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexapro, an antidepressant medicine, Physical Activity and Mood Management Skills in people with Depression, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.