WHO ICTRP trial
A study to assess the effectiveness and safety of Lumateperone as another…
CTRI/2025/03/082366 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2025/03/082366 |
|---|---|
| Public title | A study to assess the effectiveness and safety of Lumateperone as another treatment in Patients with Bipolar I Disorder (Bipolar Mania) |
| Scientific title | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania). - NIL |
| Primary sponsor | Intra-Cellular Therapies, Inc. |
| Secondary sponsors | IQVIA RDSIndia Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Bulgaria;Croatia;India;Serbia ;United States of America |
| Conditions | Health Condition 1: F316- Bipolar disorder, current episodemixed |
| Interventions | Intervention1: Lumateperone: Route: Oral Dose: Formulated Capsules (42 mg) Frequency: Once daily in the evening Control Intervention1: Placebo: Route: Oral Dose Formulation: capsule Frequency: Once daily in the evening |
| Registration date | Mar 17, 2025 |
| Target size | 350 |
| Secondary IDs | ITI-007-451 Amendment 2, dated 03 Jul 2024 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: