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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00917059
• Date of registration: 08/06/2009
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)
• Scientific title: Personalized Response Indicators of SSRI Effectiveness in Major Depression
• Date of first enrolment: May 2009
• Target sample size: 172
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00917059
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian A. Cook, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Bupropion XL

Drug: Escitalopram

Primary Outcome(s)

Score on Hamilton Depression Rating Scale (HAM-D) [Time Frame: Measured nine times over 8 weeks]

Secondary Outcome(s)

Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) [Time Frame: Measured nine times over 8 weeks]

Secondary ID(s)

R01MH085925

09-03-022-01

DSIR 84-CT

R01 MH085925

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)