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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00917059

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Escitalopram Drug: Bupropion XL	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Personalized Response Indicators of SSRI Effectiveness in Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Bupropion hydrochloride Bupropion Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Score on Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured nine times over 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) [ Time Frame: Measured nine times over 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Participants will receive a 1-week treatment of escitalopram and then an 8-week treatment with escitalopram.	Drug: Escitalopram Fixed dose of 10 mg per day
2: Active Comparator Participants will receive a 1-week treatment with escitalopram and then an 8-week treatment with bupropion XL.	Drug: Escitalopram Fixed dose of 10 mg per day Drug: Bupropion XL Fixed dose of 150 mg per day

Detailed Description:

Major depressive disorder (MDD) is a common psychiatric illness with a high cost to society and individual patients. Initial medication treatments for MDD are often ineffective, precipitating a need to try other medications. This extends suffering, continues functional disability, and increases both the risk of relapse and the risk that people will abandon treatment. Having a biological marker of likely treatment effectiveness to predict and guide clinicians' decisions would reduce the likelihood of people with MDD experiencing unsuccessful treatments. This study will test whether quantitative electroencephalogram (QEEG) measures taken after 1 week of medication treatment can predict effectiveness of a full treatment regimen with depression medications.

Participation in this study will last 8 weeks. At the first study visit, participants will undergo baseline assessments. These assessments will include an interview about present condition, medical and psychiatric history, and past and current medication treatments; a urine test; and questionnaires about depression symptoms and other possible symptoms. The study doctor may ask for other assessments based on each participant's individual profile.

Participants will then complete a 1-week treatment with escitalopram, a type of antidepressant medication called a selective serotonin reuptake inhibitor (SSRI). At the first visit and again after the week-long escitalopram treatment, participants will undergo an electroencephalogram (EEG), which measures brain electrical activity. Based on certain measurements obtained from the EEG, an antidepressant treatment response (ATR) score will be calculated.

Participants will then be divided into two treatment groups: those who continue to receive escitalopram and those who begin treatment with bupropion XL, a non-SSRI antidepressant medication. Treatment for both groups will last 8 weeks, during which time participants will attend seven study visits. At these study visits, participants will be asked about how they are feeling, side effects, and benefit from the treatment. Further tests—such as a physical exam, lab test, or EEG—may be performed if study doctors think they are necessary.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
University student or staff member directly under instruction, supervision, or employment of any of the investigators
Requires hospitalization (e.g., poses an imminent danger to self or others)
Initial quantitative EEG (QEEG) is contaminated with artifact so that determination of the biomarker is precluded
Use of medications known to affect brain function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917059

Contacts

Contact: Jennifer Villalobos	310-825-3351	info@brain.ucla.edu
Contact: Michelle Abrams, RN	310-206-0797	mabrams@brain.ucla.edu

Locations

United States, California
UCLA Semel Institute	Recruiting
Los Angeles, California, United States, 90095
Contact: Ian A. Cook, MD 310-825-0248 jpv@brain.ucla.edu
Principal Investigator: Ian Cook, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Ian A. Cook, MD

University of California, Los Angeles

More Information

No publications provided

Responsible Party:	University of California, Los Angeles ( Ian A. Cook, MD, Assoc Professor )
Study ID Numbers:	R01 MH085925, 09-03-022-01, DSIR 84-CT
Study First Received:	June 8, 2009
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00917059 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major Depressive Disorder
SSRI
EEG

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2009