How many clinical trials are studying Lithium Carbonate?

3 recruiting trials in our tracked data involve Lithium Carbonate.

What conditions is Lithium Carbonate being studied for?

In our tracked recruiting trials, Lithium Carbonate is being studied in trials for Bipolar disorder, Bipolar I Disorder, Bipolar II Disorder.

Lithium Carbonate: clinical trials recruiting now

Q: Is Lithium Carbonate FDA-approved?

Yes. According to the FDA drug label available through openFDA, Lithium Carbonate is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Lithium Carbonate appears in the FDA drug-label database. Marketed as lithium carbonate.
Boxed warning: The FDA label for Lithium Carbonate carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] • Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) • Maintenance treatment in patients 7 years and older ( 1 )

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 2 Phase 4 1

Conditions being studied

Condition	Trials
Bipolar disorder	2
Bipolar I Disorder	1
Bipolar II Disorder	1
Depression	1
Sequestra	1

Recruiting trials involving Lithium Carbonate

A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
NCT07540338 · Phase: Phase 1, Phase 2 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
NCT06184581 · Phase: Phase 4 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
NCT05814640 · Phase: Phase 1, Phase 2 · Ages: 13 Years to 18 Years · Sex: All (male and female) · 1 location

Common questions

Is Lithium Carbonate FDA-approved?

Yes, marketed as lithium carbonate. Its FDA label carries a boxed warning.

How many recruiting trials involve Lithium Carbonate?

3 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.