Effects of Treatment on Decision-making in Major Depression

NCT01916824 | Completed Phase 4 Results

• 1 other identifier: IRB00066705
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.

Conditions

Major Depressive Disorder; Healthy Controls

Keywords

depression; melancholia; treatment

Outcome Measures

Primary Outcomes (1)

• Money Earned

  Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making. The specific tasks were: 1. risk task 2. balloon analogue risk task 3. temporal discounting task 4. ultimatum game 5. continuous performance task

  Baseline, Week 6

Study Arms (2)

Participants with Major Depressive Disorder

EXPERIMENTAL

Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks

Drug: Any FDA Approved Antidepressant

Healthy Controls

NO INTERVENTION

Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness

Interventions

Any FDA Approved Antidepressant DRUG

Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.

Also known as: Sertraline, Zoloft, Citalopram, Celexa, Escitalopram, Lexapro, Paroxetine, Paxil, Fluoxetine, Prozac, Vilazodone, Viibryd, Venlafaxine XR, Effexor XR, Desvenlafaxine, Pristiq, Duloxetine, Cymbalta, Bupropion, Wellbutrin, Mirtazapine, Remeron

Participants with Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18-65
• Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
• Has a 17-item Hamilton depression rating scale (HDRS-17) score \>=16.
• Ability to visually read and understand English language
• Not currently taking an antidepressant.
• Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.
• Male or female, age 18-65
• No current DSM-IV TR diagnosis of a mental illness.
• No lifetime history of Major Depressive Disorder or Dysthymia.
• Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.
• Ability to visually read and understand English language
• Not currently taking any psychoactive medication

You may not qualify if:

• Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
• Meet criteria for substance abuse or dependence within three months of the screening visit.
• Presents with a clinically significant suicide risk, as assessed by a study physician.
• Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
• Women who are currently pregnant or lactating, or plan to become pregnant during the study.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Mood and Anxiety Disorders Program

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Interventions

Sertraline; Citalopram; Escitalopram; Paroxetine; Fluoxetine; Vilazodone Hydrochloride; Venlafaxine Hydrochloride; Desvenlafaxine Succinate; Duloxetine Hydrochloride; Bupropion; Mirtazapine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boadie Dunlop, MD
• Organization: Emory University

bdunlop@emory.edu

404-727-8969

Study Officials

• Boadie W Dunlop, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2013
• First Posted: August 6, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 21, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-10

Locations

US (1)