| CTRI Number |
CTRI/2026/02/103376 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Medicines to Improve Depressive Symptoms in Adults with Bipolar Disorder |
|
Scientific Title of Study
|
Comparative Effectiveness of Lumateperone Versus Olanzapine Fluoxetine Combination Therapy in Treating Bipolar Depression with Moderate to Severe Depressive Episode A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal Negi |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Psychiatry
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018576757 |
| Fax |
|
| Email |
sheetalnegi14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Sharma |
| Designation |
Associate Professor and Guide |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Psychiatry
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8894029445 |
| Fax |
|
| Email |
drjumbo0118@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Sharma |
| Designation |
Associate Professor and Guide |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Psychiatry
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8894029445 |
| Fax |
|
| Email |
drjumbo0118@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College,
Lakkar Bazar,
Shimla, Himachal Pradesh, 171001,
India. |
|
|
Primary Sponsor
|
| Name |
Dr Sheetal Negi |
| Address |
Postgraduate Student, Department of Psychiatry,
Indira Gandhi Medical College,
Lakkar Bazar,
Shimla, Himachal Pradesh, 171001,
India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheetal Negi |
Indira Gandhi Medical College |
Department of Psychiatry
Indira Gandhi Medical College
Shimla
Himachal Pradesh
Shimla
HIMACHAL PRADESH |
7018576757
sheetalnegi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indira Gandhi Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, (2) ICD-10 Condition: F315||Bipolar disorder, current episodedepressed, severe, with psychotic features, (3) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lumateperone |
Lumateperone is a recently developed atypical antipsychotic that has received approval for treating depressive episodes in adults with bipolar I and II disorders. Participants will receive the medication for a total duration of 8 weeks. |
| Comparator Agent |
Olanzapine Fluoxetine Combination |
The olanzapine fluoxetine combination (OFC) is an FDA approved treatment specifically indicated for the acute depressive episodes of bipolar disorder. Participants will receive the medication for a total duration of 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in HDRS, BPRS, GASS score. |
8 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary purpose of this study is to compare how well lumateperone works compared to the olanzapine–fluoxetine combination in treating adults with bipolar disorder who are currently experiencing a moderate to severe depressive episode. The study aims to assess improvement in depressive symptoms, overall clinical response, and how well patients tolerate and adhere to each treatment over an 8-week period. The study hypothesizes that lumateperone will be as effective as, or more effective than, the olanzapine–fluoxetine combination in reducing depressive symptoms in bipolar depression, with better tolerability and fewer treatment-related side effects. |