Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics

NCT00742573 | Completed Phase 2 Results DMC

• 3 other identifiers: #5692R01MH076051DSIR 83-ATSO
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Mood Disorders; Hispanic

Outcome Measures

Primary Outcomes (2)

• Mean Time of Retention

  Average number of weeks of retention of Hispanics in the treatment of MDD

  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

  Baseline

Study Arms (2)

1 Texas Medication Algorithm

ACTIVE COMPARATOR

Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression

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

Drug: Antidepressants through Texas Medication Algorithm (TMA); Behavioral: Brief Interpersonal Psychotherapy (IPT-B)

Interventions

Antidepressants through Texas Medication Algorithm (TMA) DRUG

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.

Also known as: Celexa, Lexapro, Paxil, Zoloft, Effexor XR, Wellbutrin, Cymbalta, Pamelor, Remeron

1 Texas Medication Algorithm; 2 Patient Choice

Brief Interpersonal Psychotherapy (IPT-B) BEHAVIORAL

IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.

2 Patient Choice

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hispanic males and females
• DSM-IV criteria for non-psychotic major depressive disorder (MDD) of at least moderate severity (HAM-D-17\> 18)
• Patients with stable dosage of Benzodiazepines to treat anxiety disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 30343455 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Mood Disorders

Interventions

Citalopram; Escitalopram; Paroxetine; Sertraline; Venlafaxine Hydrochloride; Bupropion; Duloxetine Hydrochloride; Nortriptyline; Mirtazapine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Propiophenones; Ketones; Thiophenes; Sulfur Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Mark Olfson, MD, MPH
• Organization: New York State Psychiatric Institute

mark.olfson@nyspi.columbia.edu

646-774-6413

Study Officials

• Carlos Blanco, MD, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: March 3, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)