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

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Bupropion XL
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder, SSRI, EEG

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Semel Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Score on Hamilton Depression Rating Scale (HAM-D)

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2009
Last Updated
February 4, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00917059
Brief Title
Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)
Official Title
Personalized Response Indicators of SSRI Effectiveness in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depressive Disorder, SSRI, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive a 1-week treatment of escitalopram and then an 8-week treatment with escitalopram.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive a 1-week treatment with escitalopram and then an 8-week treatment with bupropion XL.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Fixed dose of 10 mg per day
Intervention Type
Drug
Intervention Name(s)
Bupropion XL
Other Intervention Name(s)
Wellbutrin XL
Intervention Description
Fixed dose of 150 mg per day
Primary Outcome Measure Information:
Title
Score on Hamilton Depression Rating Scale (HAM-D)
Time Frame
Measured nine times over 8 weeks
Secondary Outcome Measure Information:
Title
Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)
Time Frame
Measured nine times over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian A. Cook, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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