Cellular Aging and Neurobiology of Depression Study

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 228
• Participant gender: Both

Summary

We are conducting an eight week longitudinal study to learn if blood levels of certain naturally occurring compounds and genetic markers differ between patients with depression and healthy adults who are not depressed, and if any such differences relate to memory performance, mood, and neurobiology.

We will do this by comparing the unmedicated depressed patients with matched healthy controls at baseline and then following the depressed patients over the course of eight weeks of standardized antidepressant treatment to gauge which baseline abnormalities normalize over the course of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)
• Treatments: Serotonin; Serotonin Uptake Inhibitors
• Last Updated: 2016-11-07

Criteria

All participants must meet the following criteria:

• Age 21-60 and able to give informed consent.

• Not "needle phobic," by self-report.

• English-speaking (to allow accurate use of behavioral rating scales and verbal cognitive tests).

• Females of child-bearing capacity must be non-pregnant (confirmed by urine pregnancy test) and using effective non-hormonal birth control (e.g. abstinence, condoms, IUD).

• Good general medical health; no significant uncontrolled illnesses.

• Clinical labs (electrolytes, liver function test, CBC) with no clinically significant abnormalities.

• Negative urine toxicology (drugs of abuse) screen.

• Taking no medication or drugs likely to interfere with the study objectives (including statins or medications that affect hormones [e.g. birth control pills or steroids]).

• Free of all psychotropic medications (including antidepressants) for at least 6 weeks (with the exception of prn short-acting benzodiazepines or sedative-hypnotics, < 3 doses per week, and none for 5 drug half-lives before the study).

• No vaccines for at least 4 weeks prior to baseline blood draw (including the flu shot).

• Not currently anemic (Hct of 36-48 for females and 38-54 for males, or Hgb of 12.5-20) and has not donated blood for at least 8 weeks prior to baseline blood draw.

• No MRI exclusions (e.g. severe claustrophobia, metal implants, pacemakers, BMI >38).

• No neurological disorders and no history of concussion with a black-out that lasted > 10 minutes.

Additional criteria for Depressed Participants:

• Current DSM-5 diagnosis of Major Depressive Disorder, unipolar, with non-psychotic features.

• Baseline 17-item Hamilton Depression Rating Scale (HDRS) rating of > 17.

• > 2.5 years since initial onset of depression and current depressive episode duration of > 6 weeks.

• No current, active suicidal intent; HDRS "suicidality" item rating < 2 OR by clinician determination.

• No recent (< 6 month) history of substance or alcohol use disorder(s), with the exception of tobacco use (DSM-5 criteria).

• No current (in the last month) diagnosis of Post-Traumatic Stress Disorder (DSM-5 criteria).

• No anticipated changes in psychotherapeutic interventions during the course of the study.

Additional criteria for Normal Controls:

• No history of DSM-5 Axis I diagnoses