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Mood Stabilizer

Lithium for Drug Mechanism

Phase 1
Waitlist Available
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men, ages 18 to 45 who are physically and mentally healthy.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

Psychiatric disorders often result from dysregulation in cellular and molecular mechanisms at the level of the brain. Unable to directly study brain tissues in patients affected by psychiatric conditions, researchers have created alternative experimental models that use different and easy to collect tissues. The underlying assumption is that by studying these "proxy" tissues, it is possible to obtain information on biological mechanisms that is a good approximation of what would be detected in the brain. One of the most established experimental models are lymphoblastoid cell lines derived from B-lymphocytes. Lymphocytes are present in the peripheral blood and can be easily collected and stored virtually forever after undergoing a special laboratory procedure that immortalize them. These cell lines have proved to be very useful in genetic and pharmacogenetic research and, using these, the investigators want to investigate the cellular effects of a mood stabilizing drug called lithium on this specific procedure that makes them virtually immortal. Two main reasons lead us to study this drug: 1) it is the most effective treatment in bipolar disorder, where approximately 30% of patients achieve complete illness remission with prevention of episode recurrence; 2) it has well established regulatory effects on the expression of specific target genes and proteins. The investigators can take advantage of these well-established properties of lithium in regulating the expression of genes, proteins, and enzymes in a stable manner. Conversely, these biological measures could be used as markers for the effects of lithium on the gene expression. The purpose of this study is to learn more about the changes in the activity of genes in cells sampled from healthy individuals treated with lithium. By studying these cellular changes, the investigators hope to understand if lymphoblastoid cell lines are valid tools in psychiatric genetics research. Specifically, the investigators want to see how specially treated lymphoblastoid cell lines are influenced by external conditions and specifically lithium treatment at the moment of sampling. To do so, the investigators will measure the gene expression (i.e. how much gene is in the cell) of lymphoblastoid cell lines and compare the levels between those sampled before and after one month of lithium treatment.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enzymatic activity of Complex I (known to be altered by lithium) analyzed in lymphoblastoid cell cultures established from lymphocytes sampled in healthy volunteers before and after one month of lithium treatment.
Expression levels of a protein, BDNF (known to be regulated by lithium) analyzed in lymphoblastoid cell cultures established from lymphocytes sampled in healthy volunteers before and after one month of lithium treatment.
Expression levels of genes (known to be regulated by lithium) analyzed in lymphoblastoid cell cultures established from lymphocytes sampled in healthy volunteers before and after one month of lithium treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LithiumExperimental Treatment1 Intervention
This will be a short-term longitudinal study of 4 weeks of duration. Twenty (20) healthy male subjects will be recruited and treated with lithium carbonate for 4 weeks. Lithium carbonate (150 mg, 300 mg, 600 mg) will be administered to the recruited subjects. The study will be performed in one centre at Capital District Health Authority - Dalhousie University, Halifax, Nova Scotia, Canada. Lithium serum levels will be tested at day 8, at day 14 and at the end of the treatment. Additional tests may be performed as necessary (as in the case of side effects).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lithium carbonate
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
259 Previous Clinical Trials
83,858 Total Patients Enrolled
Martin Alda, MD, FRCPCStudy ChairDalhousie University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby May 2025