A Study Comparing Two Medicines to Improve Depressive Symptoms in Adults with Bipolar Disorder

Comparative Effectiveness of Lumateperone Versus Olanzapine Fluoxetine Combination Therapy in Treating Bipolar Depression with Moderate to Severe Depressive Episode A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103376

Enrollment

Registered

2026-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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: F315- Bipolar disorder, current episodedepressed, severe, with psychotic features Health Condition 3: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features

Interventions

Intervention1: Lumateperone: Lumateperone is a recently developed atypical antipsychotic that has received approval for treating depressive episodes in adults with bipolar I and II disorders. Particip

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with BD (type 1 & 2) according to ICD 11 criteria 2. Both male and female patients. 3. Age group- 20 to 59 years.

Exclusion criteria

Exclusion criteria: 1. Patients with mild depressive episode. 2. Patients with organic cause of depression such as stroke, Alzheimer s, Parkinson s, intracranial tumors, epilepsy etc 3. Pregnant and lactating females. 4. Patients in which these medications are contraindicated. 5. Patient with co-morbid substance use disorder except tobacco.

Design outcomes

Primary

Measure	Time frame
Mean change in HDRS, BPRS, GASS score.Timepoint: 8 Weeks.	—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr Devesh Sharma

Indira Gandhi Medical College Shimla

drjumbo0118@gmail.com8894029445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026