Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)

NCT00917059 | Completed Phase 4 DMC

• 3 other identifiers: R01MH08592509-03-022-01DSIR 84-CT
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether measures of brain electrical signals taken after a week of antidepressant medication treatment can predict whether a full treatment regimen will be effective.

Conditions

Depression

Keywords

Major Depressive Disorder; SSRI; EEG

Outcome Measures

Primary Outcomes (1)

• Score on Hamilton Depression Rating Scale (HAM-D)

  Measured nine times over 8 weeks

Secondary Outcomes (1)

• Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)

  Measured nine times over 8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive a 1-week treatment of escitalopram and then an 8-week treatment with escitalopram.

Drug: Escitalopram

2

ACTIVE COMPARATOR

Participants will receive a 1-week treatment with escitalopram and then an 8-week treatment with bupropion XL.

Drug: Escitalopram; Drug: Bupropion XL

Interventions

Escitalopram DRUG

Fixed dose of 10 mg per day

Also known as: Lexapro

1; 2

Bupropion XL DRUG

Fixed dose of 150 mg per day

Also known as: Wellbutrin XL

2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for diagnosis of major depressive disorder (MDD) based on the Mini-International Neuropsychiatric Interview (MINI)
• Score greater than or equal to 12 on the Quick Inventory of Depressive Symptomatology - Self Rated version (QIDS-SR16)

You may not qualify if:

• Serious or unstable medical illness that would prevent complete participation in the trial, determined as needed from physical examination, electrocardiogram (ECG), laboratory safety tests, and review of systems
• Mentally or legally incapacitated and therefore unable to give informed consent
• Meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features
• Diagnosis of a DSM-IV axis II disorder that would interfere with completion of the protocol
• Would have met criteria for a diagnosis of drug dependency or substance abuse within the preceding 9 months
• Stable and in remission on current psychotropic medication(s)
• Has had a course of electroconvulsive therapy (ECT) within the past 6 months
• Started psychotherapy for the current depressive episode within the past 2 months
• Has experienced treatment failure with an adequate trial of any study medication during the current episode of depression or has failed to tolerate escitalopram in the current episode
• Known contraindication for use of any of the study drugs, including hyponatremia during past use of a selective serotonin reuptake inhibitor (SSRI)
• Treated with fluoxetine or a monoamine oxidase inhibitor (MAOI) within the past 4 weeks
• Presence of a serious or unstable medical illness, including heart, liver, kidney, respiratory, endocrine, neurologic, or blood disease severe enough to significantly affect brain function or to interfere with interpretation of study results
• History of seizures, brain surgery, skull fracture, significant head trauma, or abnormal electroencephalogram (EEG)
• Currently pregnant or of childbearing potential and not using a medically acceptable means of birth control (e.g., oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device \[IUD\], past tubal ligation, partner with vasectomy)
• Breastfeeding

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Escitalopram; Bupropion

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propiophenones; Ketones

Study Officials

• Ian A. Cook, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ian A. Cook, M.D.

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (1)