Biomarkers for Outcomes In Late-life Depression (BOLD)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01082237
• Date of registration: 05/03/2010
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Biomarkers for Outcomes In Late-life Depression (BOLD) BOLD
• Scientific title: Biomarkers for Outcomes In Late-life Depression
• Date of first enrolment: October 2009
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01082237
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, 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:

- 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)



Age minimum: 62 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

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)

1RC1MH088438

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)