Major DepressionNCT00194948
Treatment Choices for Improving Adherence and Outcome
A study testing escitalopram and interpersonal psychotherapy in people with Major Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This study will determine the effectiveness of offering primary care patients their preferred treatment versus one that is less desirable in improving treatment adherence and outcome. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- escitalopram and interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to May 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21-99
- English-speaking
- DSM-IV criteria for major depression
Who cannot join
- unable to give informed consent
- MMSE<24
- DSM-IV diagnosis of bipolar disorder, psychotic disorder, current alcohol or substance abuse
- active suicide ideation
- aphasia
- acute or severe medical illness
- currently receiving either antidepressant medication or psychotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cornell Internal Medicine Associates
New York, New York, 10021
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
Official title: Patient Preference in Primary Care Depression Treatment
This study will determine the effectiveness of offering primary care patients their preferred treatment versus one that is less desirable in improving treatment adherence and outcome.
Read the detailed description
This study investigates whether offering primary care patients treatment that is congruent with their preferred first choice improves adherence and outcomes, in comparison to offering treatment that is not congruent with their preferred first choice. All subjects are offered a treatment with demonstrated efficacy, namely either the antidepressant medication escitalopram or Interpersonal Psychotherapy for 5 months. We hypothesize that patients who receive congruent treatment will be more likely to initiate treatment, adhere to treatment, and achieve depression remission.
- Conditions
- Major Depression
- Being tested
- escitalopram, interpersonal psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
interpersonal psychotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment initiation
treatment adherence
Secondary outcomes (1)
depressive symptomatology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Patrick J Raue, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194948
- Sponsor's protocol ID
- K23MH069784
- Other IDs
- K23MH069784, DSIR 8K-RTSE
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 4 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference in Primary Care Depression Treatment
- ClinicalTrials.gov ID
- NCT00194948
- Acronym / sponsor ID
- K23MH069784
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 19 Sep 2005 (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.
This study will determine the effectiveness of offering primary care patients their preferred treatment versus one that is less desirable in improving treatment adherence and outcome.
Detailed description
This study investigates whether offering primary care patients treatment that is congruent with their preferred first choice improves adherence and outcomes, in comparison to offering treatment that is not congruent with their preferred first choice. All subjects are offered a treatment with demonstrated efficacy, namely either the antidepressant medication escitalopram or Interpersonal Psychotherapy for 5 months. We hypothesize that patients who receive congruent treatment will be more likely to initiate treatment, adhere to treatment, and achieve depression remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 21-99
- English-speaking
- DSM-IV criteria for major depression
Key exclusion criteria (7 listed)
- unable to give informed consent
- MMSE<24
- DSM-IV diagnosis of bipolar disorder, psychotic disorder, current alcohol or substance abuse
- active suicide ideation
- aphasia
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 |
|---|---|---|
| escitalopram | Drug | – |
| interpersonal psychotherapy | Behavioural | – |
Primary outcome
treatment initiation
treatment adherence
1 secondary outcome
depressive symptomatology
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 4 Nov 2013.
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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.
Patrick J Raue, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing escitalopram and interpersonal psychotherapy in people with Major Depression, run by Weill Medical College of Cornell University at 2 sites 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 3 inclusion and 7 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
treatment initiation. The study lists 2 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 4 Nov 2013.