L-Theanine as an adjuvant therapy in the treatment of major depressive disorder

L-Theanine as an adjuvant therapy in the treatment of major depressive disorder: a double-blind, randomized, placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N131

Enrollment

Registered

2020-05-28

Start date

2020-06-30

Completion date

Unknown

Last updated

2020-06-15

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, severe without psychotic features

Interventions

Intervention 1: Intervention group: Sertraline tablet (Sobhan co.) 100 mg per day + L-Theanine tablet (ACECR) 200 mg per day for 6 weeks. Intervention 2: Control group: Sertraline tablet (Sobhan co.)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of major depressive disorder, based on DSM-5 Age between 18 to 60 years The minimum score of 19, based on Hamilton depression scale

Exclusion criteria

Exclusion criteria: Drug use during 1 year prior to trial (except nicotine) Receive psychotropic drugs during 1 month prior to trial History of Electroconvulsive therapy, two months prior to the trial Psychosis History of at least one period of mania or hypomania or mixed Serious suicidal thoughts (The score of >2 in Hamilton depression scale, the suicidal tendencies section) Kidney, liver, cardiovascular, or thyroid disorders Pregnant or lactating women Presence of concomitant psychiatric disorders The patient's own request to leave the study

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks 2, 4, and 6. Method of measurement: By Hamilton depression scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin 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