Last reviewed · How we verify
Placebo plus Lithium
Lithium modulates intracellular signaling pathways, particularly inhibiting glycogen synthase kinase-3 (GSK-3) and affecting monoamine neurotransmitter systems to stabilize mood.
Lithium modulates intracellular signaling pathways, particularly inhibiting glycogen synthase kinase-3 (GSK-3) and affecting monoamine neurotransmitter systems to stabilize mood. Used for Bipolar disorder (acute mania and maintenance treatment), Major depressive disorder (augmentation therapy), Suicidal behavior prevention in mood disorders.
At a glance
| Generic name | Placebo plus Lithium |
|---|---|
| Sponsor | Shanghai Mental Health Center |
| Drug class | Mood stabilizer |
| Target | GSK-3 (glycogen synthase kinase-3), inositol monophosphatase |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Lithium is a mood stabilizer that works through multiple mechanisms including inhibition of inositol monophosphatase and GSK-3, which affects intracellular signaling cascades involved in neuroplasticity and neuroprotection. It also modulates serotonin and norepinephrine neurotransmission. The 'placebo plus' designation indicates this is a combination study design comparing lithium with placebo control.
Approved indications
- Bipolar disorder (acute mania and maintenance treatment)
- Major depressive disorder (augmentation therapy)
- Suicidal behavior prevention in mood disorders
Common side effects
- Tremor
- Polyuria and polydipsia
- Cognitive dulling
- Weight gain
- Nausea
- Hypothyroidism
- Nephrogenic diabetes insipidus
Key clinical trials
- LiO-AD: Lithium Orotate in Alzheimers Disease Feasibility, Biomarker Engagement, and Clinical Response (PHASE1, PHASE2)
- A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine (PHASE3)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency) (PHASE3)
- Lithium As a Treatment to Prevent Impairment of Cognition in Elders (PHASE4)
- Repurposing Lithium for Parkinson's Disease: a RCT (PHASE1, PHASE2)
- Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS) (PHASE3)
- Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo plus Lithium CI brief — competitive landscape report
- Placebo plus Lithium updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI