Phase
Condition
Depression (Treatment-resistant)
Depression
Depression (Major/severe)
Treatment
Lithium
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria for BD subjects:
ages 18-60 years (inclusive) and able to give voluntary informed consent;
Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD I or II, current Depressive Episode;
17-item Hamilton Depression Rating Scale (HAM-D) score >15 and <25;
Young Mania Rating Scale (YMRS) < 8;
no psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks) OR on stable psychotropic medications for 12 weeks
no lithium treatment for past 6 months;
satisfy criteria to undergo an MRI scan based on MRI screening questionnaire;
able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale < 5 (i.e., moderately ill) and no significant suicidal or homicidal ideation or gross disability.
Exclusion criteria for BD subjects are:
meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
a primary diagnosis;
requiring inpatient treatment;
meeting DSM-V criteria for substance dependence within the past 3 months, except caffeine or nicotine;
positive urinary toxicology screening at screening visit;
use of alcohol in the past 1 week;
serious medical or neurological illness;
current pregnancy or breast feeding;
metallic implants or other contraindications to MRI.
Inclusion criteria for healthy subjects:
ages 18-60 years and ability to give voluntary informed consent;
no history of psychiatric illness or substance abuse or dependence;
no significant family history of psychiatric or neurological illness in first degree relative;
not currently taking any prescription or centrally acting medications;
no use of alcohol in the past 1 week;
and no serious medical or neurological illness.
Exclusion criteria for healthy subjects are:
under 18 years of age;
pregnant or breast-feeding;
metallic implants or other contraindication to MRI.
Study Design
Study Description
Connect with a study center
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio 44195
United StatesSite Not Available
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