DepressionNCT00057642
Improving Retention of Hispanics Receiving Antidepressant Therapy
A study testing Sertraline and Venlafaxine Extended Release in people with Depression and Depressive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Sertraline and Venlafaxine Extended Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2006
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic Statistical Manual, 4th edition criteria for Major Depressive Disorder
- Patients who self-identify as Hispanic and are Spanish-dominant, English-dominant, or bilingual
- Acceptable methods of contraception
- Hamilton Depression Rating Scale score >= 18 at Visit 1
- Sertraline or venlafaxine ER is clinically appropriate
Who cannot join
- History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndrome
- DSM-IV criteria for alcohol or substance abuse or dependence during the 6 months prior to screening
- Pregnancy or breast-feeding
- At risk for committing suicide
- Clinically significant renal, pulmonary, cerebrovascular, cardiovascular, gastrointestinal, or endocrine disorders
- Glaucoma, history of increased intraocular pressure (IOP), or at risk for having increased IOP
Show all 17Show fewer
- Untreated or unstable hypertension
- Clinically significant laboratory abnormalities or abnormal electrocardiogram
- Medical conditions that might interfere with the process of drug absorption, metabolism, or elimination
- Clinically significant thyroid dysfunction (except patients who are stable and asymptomatic on thyroid replacement therapy)
- Current or past history of seizure disorder (except febrile seizure in childhood)
- History of failed sertraline or venlafaxine treatment for at least 4 weeks at adequate doses
- Allergy or hypersensitivity to sertraline or venlafaxine
- History of two failed selective serotonin reuptake inhibitor (SSRI) trials for major depression at adequate doses and duration
- Monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or other SSRIs, antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs (except zolpidem for insomnia) within 2 weeks prior to screening
- Electroconvulsive Therapy (ECT) within the last 3 months
- Effective medication or psychotherapy
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 Hispanic Retention in Antidepressant Therapy
This study will develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
Read the detailed description
Despite major advances in the treatment of psychiatric disorders, Hispanics continue to underutilize mental health services relative to their own mental health needs. Cultural factors are important causes of underutilization. To date, however, attempts to boost utilization by improving the cultural congruence of psychiatric services have not focused on retaining Hispanics in antidepressant therapy.
Motivational Interviewing (MI) is a time-limited psychotherapy that has successfully improved treatment retention among patients with dually diagnosed substance abuse and psychiatric disorders. During Phase I of this study, MI is adapted for use as an adjunctive therapy with antidepressant treatment and culturally adapted to Hispanic participants. In Phase II, participants receive sertraline for 12 weeks and participate in four sessions of MI therapy as a supplementary intervention designed to encourage treatment retention. Participants who are intolerant to sertraline or have an inadequate response by Week 6 are switched to venlafaxine ER while continuing to receive MI and to complete study assessments. A follow-up interview is conducted 6 months after the termination of treatment.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Sertraline, Venlafaxine Extended Release
- Keywords
- Hispanic Americans
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Venlafaxine Extended ReleaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Sertraline, venlafaxine, bupropion | Other | This is an open trial so there is only one arm using standard antidepressant medications. Receives: Drug: Sertraline; Drug: Venlafaxine Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention percentage
The proportion of weeks in treatment
Measured: 12 weeks
Secondary outcomes (4)
Depressive symptoms on the Hamilton Depression scale
Measured: 12 weeks
Number of days in treatment
Sum of days in treatment
Measured: 84 days
Functional impairment on the Sheehan Disability Scale
Measured: 12 weeks
Perceived quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2003 (estimated)
- Study startSep 2002
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- Sponsor
- Investigators
- Roberto Lewis-Fernandez, MD, Principal investigator, Columbia University, NY State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057642
- Sponsor's protocol ID
- #4358
- Other IDs
- R21MH066388, DSIR SE-SC
- Status last verified
- Sep 2008
- First submitted
- 4 Apr 2003
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis-Fernandez R, Balan IC, Patel SR, Sanchez-Lacay JA, Alfonso C, Gorritz M, Blanco C, Schmidt A, Jiang H, Schneier F, Moyers TB. Impact of motivational pharmacotherapy on treatment retention among depressed Latinos. Psychiatry. 2013 Fall;76(3):210-22. doi: 10.1521/psyc.2013.76.3.210.
PubMed 23965261
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hispanic Retention in Antidepressant Therapy
- ClinicalTrials.gov ID
- NCT00057642
- Acronym / sponsor ID
- #4358
- Conditions
- Depression, Depressive Disorder
- Keywords
- Hispanic Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 Apr 2003 (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 develop an intervention that will increase the retention of Hispanics with major depression in antidepressant therapy.
Detailed description
Despite major advances in the treatment of psychiatric disorders, Hispanics continue to underutilize mental health services relative to their own mental health needs. Cultural factors are important causes of underutilization. To date, however, attempts to boost utilization by improving the cultural congruence of psychiatric services have not focused on retaining Hispanics in antidepressant therapy.
Motivational Interviewing (MI) is a time-limited psychotherapy that has successfully improved treatment retention among patients with dually diagnosed substance abuse and psychiatric disorders. During Phase I of this study, MI is adapted for use as an adjunctive therapy with antidepressant treatment and culturally adapted to Hispanic participants. In Phase II, participants receive sertraline for 12 weeks and participate in four sessions of MI therapy as a supplementary intervention designed to encourage treatment retention. Participants who are intolerant to sertraline or have an inadequate response by Week 6 are switched to venlafaxine ER while continuing to receive MI and to complete study assessments. A follow-up interview is conducted 6 months after the termination of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sertraline, venlafaxine, bupropion | Other | Drug: Sertraline, Drug: Venlafaxine Extended ReleaseThis is an open trial so there is only one arm using standard antidepressant medications. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnostic Statistical Manual, 4th edition criteria for Major Depressive Disorder
- Patients who self-identify as Hispanic and are Spanish-dominant, English-dominant, or bilingual
- Acceptable methods of contraception
- Hamilton Depression Rating Scale score >= 18 at Visit 1
- Sertraline or venlafaxine ER is clinically appropriate
Key exclusion criteria (17 listed)
- History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndrome
- DSM-IV criteria for alcohol or substance abuse or dependence during the 6 months prior to screening
- Pregnancy or breast-feeding
- At risk for committing suicide
- Clinically significant renal, pulmonary, cerebrovascular, cardiovascular, gastrointestinal, or endocrine disorders
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 |
|---|---|---|
| Sertraline | Drug | Sertraline, venlafaxine, bupropion |
| Venlafaxine Extended Release | Drug | Sertraline, venlafaxine, bupropion |
Primary outcome
Retention percentage
Time frame: 12 weeks
The proportion of weeks in treatment
4 secondary outcomes
Depressive symptoms on the Hamilton Depression scale
Time frame: 12 weeks
Number of days in treatment
Time frame: 84 days
Functional impairment on the Sheehan Disability Scale
Time frame: 12 weeks
Perceived quality of life
Time frame: 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 20 Aug 2013.
- Derived from this study: PubMed 23965261Lewis-Fernandez R, Balan IC, Patel SR, Sanchez-Lacay JA, Alfonso C, Gorritz M, Blanco C, Schmidt A, Jiang H, Schneier F, Moyers TB. Impact of motivational pharmacotherapy on treatment retention among depressed Latinos. Psychiatry. 2013 Fall;76(3):210-22. doi: 10.1521/psyc.2013.76.3.210.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Roberto Lewis-Fernandez, MD principal investigator
Columbia University, NY 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 study testing Sertraline and Venlafaxine Extended Release in people with Depression and 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 5 inclusion and 17 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 20 Aug 2013. 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?
Retention percentage (time frame: 12 weeks). 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 NCT00057642, 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 20 Aug 2013.