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Anticonvulsant

Lithium for Bipolar Disorder

N/A
Waitlist Available
Led By Ramin Parsey, MD, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PATIENTS
BIPOLAR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This study is evaluating whether there are differences in serotonin transporter binding potential between bipolar disorder patients and healthy controls.

Eligible Conditions
  • Bipolar Disorder
  • Depression, Bipolar Disorder
  • Major Depressive Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Prediction of Treatment Response
Secondary outcome measures
Group Differences in 5-HT1A Binding Potential
Group Differences in 5-HTT Binding Potential
Relationship Between Change in 5-HTT or 5-HT1A Binding Potential Pre- to Post Treatment and Lithium Treatment Response

Trial Design

2Treatment groups
Experimental Treatment
Group I: LithiumExperimental Treatment1 Intervention
Patients in this condition will receive lithium administered as follows: Day 1, 2 and 3, 300 mg bid; Days 4-7 lithium 300 qam and 600 qhs. Lithium level will be checked as close to Day 7 as possible and titrated to a therapeutic plasma level of 0.8-1.2 mEq/l. Subjects will not undergo lithium monotherapy if they have a documented history of at least two failed trials of lithium of at least 4 weeks duration with therapeutic blood levels for a major depressive episode
Group II: LamotrigineExperimental Treatment1 Intervention
Patients who have not respond to adequate prior lithium treatment while depressed, or who refuse lithium, will be given lamotrigine. Lamotrigine will be started at 25 mg bid and increased to 50 mg bid after 2 weeks and again increased to 100 mg bid after an additional 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lithium
2001
Completed Phase 4
~2470
Lamotrigine
2011
Completed Phase 4
~2490

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,451 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,227 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,509 Patients Enrolled for Bipolar Disorder
The Dana FoundationOTHER
17 Previous Clinical Trials
908 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025