Lithium salts are mood-stabilizing psychiatric medications used primarily for bipolar disorder and also in selected depressive and other psychiatric settings. Lithium is administered orally and requires therapeutic drug monitoring because of a narrow therapeutic index. FDA approval for bipolar disorder dates to 1970.
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
Recent studies demonstrate brain stimulation therapies can accelerate depression treatment to five days and low-dose lithium may slow cognitive decline in seniors with mild cognitive impairment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06929273 |
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) |
RECRUITING | PHASE3 |
| NCT06751875 |
Preventing Relapse After Successful Electroconvulsive Therapy for Depression |
COMPLETED | NA |
| NCT06729970 |
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants |
COMPLETED | PHASE1 |
| NCT06051240 |
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy |
RECRUITING | PHASE2 |
| NCT06005155 |
Lithium Versus Anticonvulsants and the Risk of Physical Disorders |
COMPLETED | |
| NCT05973786 |
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. |
RECRUITING | PHASE3 |
| NCT05923476 |
Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study |
UNKNOWN | EARLY_PHASE1 |
| NCT05913947 |
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) |
RECRUITING | PHASE4 |
| NCT05618587 |
Effect of Lithium Therapy on Long COVID Symptoms |
COMPLETED | PHASE2 |
| NCT05603104 |
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure |
RECRUITING | PHASE3 |
