Status:
ACTIVE_NOT_RECRUITING
Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Bipolar Disorder
Bipolar I Depression
Eligibility:
All Genders
18-60 years
Brief Summary
Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of...
Detailed Description
The premise of this proposal is that the clinical efficacy of lithium in bipolar disorder, and its complex effects on multiple brain physiological functions, may be best deciphered using a network pro...
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.
Exclusion
Key Trial Info
Start Date :
December 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03336918
Start Date
December 7 2017
End Date
December 1 2025
Last Update
July 2 2025
Active Locations (1)
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1
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, United States, 44195