Biomarkers for Outcomes In Late-life Depression (BOLD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ian A. Cook, M.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01082237
First received: March 5, 2010
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

Major depressive disorder (MDD) is a common psychiatric illness with high cost to society and individual patients. One reason for the high cost is that most patients endure lengthy and ultimately unsuccessful empiric antidepressant trials before a successful medication is identified by trial-and-error. Care would be improved if a biomarker could determine, early in the course of treatment, whether a particular antidepressant would likely lead to response, remission, or treatment failure. Physicians could rapidly change treatments to an antidepressant which the biomarker indicated would be likely to help the patient. We have identified quantitative electroencephalographic (QEEG) changes that emerge early in the course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to predict later response and remission in a general adult patient population. Demographic trends in the United States suggest that improved care for MDD will be essential for a growing number of elderly with late-life depression. While the consequences of prolonged trial-and-error periods to find a successful treatment are particularly inauspicious for elders with late-life depression, this patient group has not been included in the past studies which demonstrated the use of this biomarker approach in a general adult population. We propose a 12-week treatment trial to evaluate a practical biomarker for predicting outcome based on data from the first week of antidepressant treatment, with a focus only on depression in late life (age ≥65).

There are three study Hypothesis:

H1) ATR prediction of treatment outcome in older subjects will show >70% accuracy.

H2) The predictive accuracy of the model will be enhanced by including clinical, socio-demographic, and genetic predictors.

H3) The accuracy of ATR prediction will not show a significant dependence on subject gender.


Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biomarkers for Outcomes In Late-life Depression

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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 ]

Enrollment: 80
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: escitalopram
All subjects will receive escitalopram (ESC), brand name Lexapro (Forest Laboratories, Inc., New York) throughout the study. Dosing will start at 5 mg/d, be titrated to 10 mg after 4 days, and continue at 10 mg/d thereafter; an additional dose titration to 20 mg will be pursued at week 8 for those not significantly better (<50% improvement on IDS-30 at week 8 visit) and as tolerated.
Drug: Escitalopram
Start at 5mg per day, after four days increase to 10mg per day for the duration of the study. 20 mg will be administered at week 8 if not significantly better.
Other Name: Lexapro

  Eligibility

Ages Eligible for Study:   62 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 62 years of age or older
  • Meet the DSM-IV diagnosis of MDD based on Sheehan's Mini-International Neuropsychiatric Interview (MINI), with a score of > 28 on the 30-item Inventory of Depressive Symptomatology - Self Rated version (IDS-SR30)

Exclusion Criteria:

  • Subjects will have no unstable medical illness that would prevent completion of participation in the trial, determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems
  • mentally or legally incapacitated, 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
  • MMSE (Folstein et al., 1975) score ≤ 24
  • evidence of drug dependency or substance abuse within the preceding nine months
  • stable and in remission on current psychotropic medication(s)
  • any ECT within the past six months
  • failure to tolerate ESC or treatment failure with an adequate trial of ESC in the current episode
  • ESC would be contraindicated (e.g., hyponatremia with a prior SSRI)
  • treatment with fluoxetine or an MAOI within the past four weeks
  • any medical illness 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 EEG
  • psychiatric hospitalization indicated (e.g., imminent danger to self or others)
  • initial QEEG recording is contaminated with artifact so that determination of the biomarker is precluded
  • use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines - same list as in BRITE-MD)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082237

Locations
United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Ian A Cook, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Ian A. Cook, M.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01082237     History of Changes
Other Study ID Numbers: 1RC1MH088438, 1RC1MH088438
Study First Received: March 5, 2010
Last Updated: April 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Major Depressive Disorder
EEG
SSRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014