Lumateperone as adjuvant therapy for major depressive disorder

Lumateperone as adjuvant therapy to sertraline in major depressive disorder: A randomized double blind and placebo controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N141

Enrollment

Registered

2022-03-01

Start date

2022-04-21

Completion date

Unknown

Last updated

2022-03-08

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

Conditions

Major depressive disorder. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: received sertraline at a dose of 100 mg / day, and Lumateperone at a dose of 42 mg / day for 8 weeks. Intervention 2: Control group: received sertraline at a dose o

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Based on DSM-V have a diagnosis of major depression (MDD) and their minimum severity of depression based on HDRS is 19 Age between 18-65

Exclusion criteria

Exclusion criteria: Any other mental disorder in another axis Serious suicidal thoughts (<2 in suicidal HDRS section) Psychosis History of ECT in recent two months History of mania and hypomania Thyroid dysfunctions History of cardiovascular disease Diabetes Autoimmune disorders Presence of active infection Neurologic disorders like epilepsy and Alzheimer's disease Liver disease Kidney disease Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Weeks 0 - 4 - 8. Method of measurement: by Hamiltion Depression Rating Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026