An RCT for bipolar depression comparing Lumateperone with olanzapine fluoxetine combination.

A Randomized Controlled Trial to Compare the Efficacy and Safety of Lumateperone Versus Olanzapine-Fluoxetine Combination in the Treatment of Bipolar Depression

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107270

Enrollment

Registered

2026-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity Health Condition 2: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features Health Condition 3: F315- Bipolar disorder, current episodedepressed, severe, with psychotic features

Interventions

Intervention1: Lumateperone 42 mg: Lumateperone, a novel atypical antipsychotic, approved by the US FDA in 2021 for bipolar depression, acts via multiple mechanisms: 5-HT2A receptor antagonism, dopami

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with Bipolar 1/2 disorder, currently in depressive episode as per DSM 5 Criteria BMI between 18 and 25 km/m2 On stable dose of lithium/valproate for 2 weeks prior MADRS equal or greater than 20 and YMRS less than 12

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity to either study medication or their components. 2. Current or past diagnosis of schizophrenia, schizoaffective disorder, or primary substance use disorder (excluding nicotine) in the past 6 months. 3. Recent hospitalization for manic episode within the last 2 weeks. 4. History of seizure disorder or serious neurological condition (e.g., epilepsy, dementia, traumatic brain injury). 5. Ongoing treatment with antipsychotics, antidepressants, or mood stabilizers that cannot be safely discontinued (except lithium or valproate). 6. Use of CYP3A4 inducers/inhibitors or strong CNS-active agents (e.g., sedatives, opioids, immunosuppressants) within the past 7 days. 7. Presence of uncontrolled medical illness, including: o Cardiovascular disease with prolonged QTc o Abnormal liver/renal function o Severe endocrine disturbance 8. Current pregnancy, breastfeeding, or planning for major surgery during study duration.

Design outcomes

Primary

Measure	Time frame
Change in MADRS score from baseline to the end of each 4-week treatment phase (Lumateperone and OFC).Timepoint: weekly till 12 weeks	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactRohit Guleria

AIIMS BATHINDA

anejajitender@gmail.com9728266339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026