Major Depressive DisorderPhase 2NCT00742573
Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
A Phase 2 study testing Antidepressants through Texas Medication Algorithm (TMA) and Brief Interpersonal Psychotherapy (IPT-B) in people with Major Depressive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Antidepressants through Texas Medication Algorithm (TMA) and Brief Interpersonal Psychotherapy (IPT-B)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 10 Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hispanic males and females
- DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18)
- 18- 79
- Patients with stable dosage of Benzodiazepines to treat anxiety disorders
Who cannot join
- At risk of attempting suicide
- Unstable medical illness
- History of bipolar disorder, schizophrenia, or other psychotic disorder
- Pregnant or lactating
- Alcohol or substance use disorder that requires acute detoxification
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Improving the Effectiveness of Treatment for Depression in Hispanics
This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.
Read the detailed description
Retention of Hispanics in the treatment of major depressive disorder (MDD) continues to be a major public health problem. Hispanics drop out from treatment two to three times more frequently than non-Hispanic whites, despite the scarcity of treatment alternatives for Hispanics and their low rates of re-entry into the mental health care system. Consistent with the goals of Healthy People 2010 and the President's New Freedom Commission on Mental Health, the goal of this study is to test the efficacy in a research setting of a novel intervention to improve retention and response. This efficacy assessment would serve as a reference point for the development of future effectiveness trials in community settings.
Our intervention is founded on growing evidence that when depressed Hispanics seek help for mental health problems, they prefer to receive psychotherapy or combined treatment in the form of weekly in-person clinic visits. However, socioeconomic barriers, such as low-paying jobs with irregular hours, lack of child care, and limited time availability, often reduce treatment retention and result in dropout rates up to three times those of non-Hispanic whites. Based on emerging literature and on promising pilot data, we propose to study the efficacy for depressed Hispanics of an intervention that would allow for patient choice between the following options: 1) Medication alone, following the Texas Medication Algorithm for Depression (TMA); 2) Brief Interpersonal Psychotherapy (IPT-B) alone, with optional telephone sessions; or 3) Combined medication plus IPT-B. This intervention would allow switching of treatment modality (e.g., from IPT-B alone to combined treatment) at any point during the study period. We hypothesize that by permitting patient choice among evidence-based treatments, flexibility in the sequential use of treatments, and novel treatment delivery systems, this intervention will substantially increase retention of Hispanics in MDD treatment. Furthermore, we will examine mediators and moderators of retention, including stigma and insurance coverage.
We propose to test this intervention in depressed Hispanics seeking outpatient psychiatric treatment using a randomized trial with TMA as the control group. Both groups will have access to medication using the TMA but only one group will be offered IPT_B. . We will test the association between treatment, retention, and response over the course of acute MDD care (12 weeks), and will also obtain preliminary outcome data after 9 more months of treatment (i.e., for a total of 12 months). Our pilot data enable us to estimate the sample size for the acute phase, while the additional follow-up period allows us to examine the effect of choice over the longer-term course of MDD care.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressants through Texas Medication Algorithm (TMA), Brief Interpersonal Psychotherapy (IPT-B)
- Keywords
- Major Depressive Disorder, Mood Disorders, Hispanic
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antidepressants through Texas Medication Algorithm (TMA)Drug
Also called Celexa, Lexapro, Paxil, Zoloft
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Brief Interpersonal Psychotherapy (IPT-B)Behavioural
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
| Study group | Role | What they receive |
|---|---|---|
| 1 Texas Medication Algorithm | Active comparator | Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression Receives: Drug: Antidepressants through Texas Medication Algorithm (TMA) |
| 2 Patient Choice | Experimental | Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression Receives: Drug: Antidepressants through Texas Medication Algorithm (TMA); Behavioral: Brief Interpersonal Psychotherapy (IPT-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time of Retention
Average number of weeks of retention of Hispanics in the treatment of MDD
Measured: 52 weeks
Hamilton Depression Scale (HAMD-17)
Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse.
0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression
Minimum is 0 and the maximum score being 52
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startAug 2008
- Primary completion10 Jan 2014
- Study completion10 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mark Olfson, New York State Psychiatric Institute
- Investigators
- Carlos Blanco, MD, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742573
- Sponsor's protocol ID
- #5692
- Other IDs
- R01MH076051, DSIR 83-ATSO
- Status last verified
- Feb 2020
- First submitted
- 25 Aug 2008
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to make individual participant available to other researchers at this time.
Publications
Blanco C, Markowitz JC, Hellerstein DJ, Nezu AM, Wall M, Olfson M, Chen Y, Levenson J, Onishi M, Varona C, Okuda M, Hershman DL. A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer. Breast Cancer Res Treat. 2019 Jan;173(2):353-364. doi: 10.1007/s10549-018-4994-5. Epub 2018 Oct 20.
PubMed 30343455
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Effectiveness of Treatment for Depression in Hispanics
- ClinicalTrials.gov ID
- NCT00742573
- Acronym / sponsor ID
- #5692
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Mood Disorders, Hispanic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- 10 Jan 2014 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Posted 3 Mar 2020
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 whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.
Detailed description
Retention of Hispanics in the treatment of major depressive disorder (MDD) continues to be a major public health problem. Hispanics drop out from treatment two to three times more frequently than non-Hispanic whites, despite the scarcity of treatment alternatives for Hispanics and their low rates of re-entry into the mental health care system. Consistent with the goals of Healthy People 2010 and the President's New Freedom Commission on Mental Health, the goal of this study is to test the efficacy in a research setting of a novel intervention to improve retention and response. This efficacy assessment would serve as a reference point for the development of future effectiveness trials in community settings.
Our intervention is founded on growing evidence that when depressed Hispanics seek help for mental health problems, they prefer to receive psychotherapy or combined treatment in the form of weekly in-person clinic visits. However, socioeconomic barriers, such as low-paying jobs with irregular hours, lack of child care, and limited time availability, often reduce treatment retention and result in dropout rates up to three times those of non-Hispanic whites. Based on emerging literature and on promising pilot data, we propose to study the efficacy for depressed Hispanics of an intervention that would allow for patient choice between the following options: 1) Medication alone, following the Texas Medication Algorithm for Depression (TMA); 2) Brief Interpersonal Psychotherapy (IPT-B) alone, with optional telephone sessions; or 3) Combined medication plus IPT-B. This intervention would allow switching of treatment modality (e.g., from IPT-B alone to combined treatment) at any point during the study period. We hypothesize that by permitting patient choice among evidence-based treatments, flexibility in the sequential use of treatments, and novel treatment delivery systems, this intervention will substantially increase retention of Hispanics in MDD treatment. Furthermore, we will examine mediators and moderators of retention, including stigma and insurance coverage.
We propose to test this intervention in depressed Hispanics seeking outpatient psychiatric treatment using a randomized trial with TMA as the control group. Both groups will have access to medication using the TMA but only one group will be offered IPT_B. . We will test the association between treatment, retention, and response over the course of acute MDD care (12 weeks), and will also obtain preliminary outcome data after 9 more months of treatment (i.e., for a total of 12 months). Our pilot data enable us to estimate the sample size for the acute phase, while the additional follow-up period allows us to examine the effect of choice over the longer-term course of MDD care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Texas Medication Algorithm | Active comparator | Drug: Antidepressants through Texas Medication Algorithm (TMA)Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression |
| 2 Patient Choice | Experimental | Drug: Antidepressants through Texas Medication Algorithm (TMA), Behavioral: Brief Interpersonal Psychotherapy (IPT-B)Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hispanic males and females
- DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17> 18)
- 18- 79
- Patients with stable dosage of Benzodiazepines to treat anxiety disorders
Key exclusion criteria (5 listed)
- At risk of attempting suicide
- Unstable medical illness
- History of bipolar disorder, schizophrenia, or other psychotic disorder
- Pregnant or lactating
- Alcohol or substance use disorder that requires acute detoxification
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 |
|---|---|---|
| Antidepressants through Texas Medication Algorithm (TMA)Also: Celexa, Lexapro, Paxil, ZoloftTreatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine. | Drug | 1 Texas Medication Algorithm, 2 Patient Choice |
| Brief Interpersonal Psychotherapy (IPT-B)IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems. | Behavioural | 2 Patient Choice |
Primary outcome
Mean Time of Retention
Time frame: 52 weeks
Average number of weeks of retention of Hispanics in the treatment of MDD
Hamilton Depression Scale (HAMD-17)
Time frame: Baseline
Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression Minimum is 0 and the maximum score being 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30343455Blanco C, Markowitz JC, Hellerstein DJ, Nezu AM, Wall M, Olfson M, Chen Y, Levenson J, Onishi M, Varona C, Okuda M, Hershman DL. A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer. Breast Cancer Res Treat. 2019 Jan;173(2):353-364. doi: 10.1007/s10549-018-4994-5. Epub 2018 Oct 20.
- Individual participant dataSharing planned: No. There is no plan to make individual participant available to other researchers at this time.
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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.
Carlos Blanco, MD, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antidepressants through Texas Medication Algorithm (TMA) and Brief Interpersonal Psychotherapy (IPT-B) in people with Major Depressive Disorder, run by New York State Psychiatric Institute 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 4 inclusion and 5 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 3 Mar 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Time of Retention (time frame: 52 weeks). 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?
On the ClinicalTrials.gov record for NCT00742573, which also lists 1 linked publication.
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 3 Mar 2020.