Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Nov 6, 2017

Keywords

ClinConnect Summary

This clinical trial is studying how lithium, a common medication for bipolar disorder, affects the brain's connections and structure. Researchers want to see how lithium treatment changes the way different parts of the brain communicate with each other, using special MRI scans to observe these changes. This is an important study because it aims to understand the benefits of lithium better, which could help improve treatment for people with bipolar disorder.

To participate, you should be between 18 and 60 years old and have been diagnosed with either Bipolar I or II disorder, currently experiencing a depressive episode. Participants should not have taken lithium or certain other medications recently and must be in a stable condition where they can be managed as outpatients. If you decide to join, you will undergo MRI scans and assessments to track how your brain responds to lithium treatment. It's also important to know that healthy volunteers without any psychiatric history can participate, helping researchers compare results.

Gender

ALL

Eligibility criteria

• 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.