a clinical trial to study the effect of drug L-theanine on patients with major depressive disorder.

Effect of L-Theanine as an Adjunct to Standard Antidepressant Therapy in Patients with Major Depressive Disorder: A Randomized, Double Blind, Placebo Controlled Study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111806

Enrollment

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

Interventions

Intervention1: L theanine 200mg: L theanine 200mg will be given at night for 42 days Control Intervention1: Placebo: GLucose tablets identical in size and shape to L theanine 200mg will be given at ni

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients of either sex aged 18-60 years with a clinical diagnosis of MDD as per DSM-5 criteria. Patients on a stable dose of antidepressant (no change in dose) for at least 4 weeks. Patients willing to participate and give written informed consent.

Exclusion criteria

Exclusion criteria: Patients with comorbid psychiatric or neurological disorders and substance use disorders (except nicotine replacement therapy). Patients with unstable medical illnesses or any active malignancy. Concurrent use of any psychotropic medications other than benzodiazepines. Patients on antihypertensives. Patients with known hypersensitivity to L-theanine or Camellia sinensis. Pregnancy, lactation, or planning to get pregnant during the treatment period.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of 42 days of adjunct L-theanine therapy on depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS) in patients with major depressive disorder (MDD) on standard antidepressant therapy.Timepoint: At baseline and 42 days	—

Secondary

Measure	Time frame
To evaluate the change in the Montgomery- sberg Depression Rating Scale (MADRS) after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days;To evaluate the change in serum BDNF levels after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days;To evaluate the change in serum IL-6 levels after 42 days of adjunct L-theanine therapy.Timepoint: At baseline and 42 days;To evaluate the change in TNF-alpha levels after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days	—

Measure

Time frame

To evaluate the change in the Montgomery- sberg Depression Rating Scale (MADRS) after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days;To evaluate the change in serum BDNF levels after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days;To evaluate the change in serum IL-6 levels after 42 days of adjunct L-theanine therapy.Timepoint: At baseline and 42 days;To evaluate the change in TNF-alpha levels after 42 days of adjunct L-theanine therapy. Timepoint: At baseline and 42 days

—

Countries

India

Contacts

Public ContactDr KH Reeta

All Institute of Medical Sciences,New Delhi

reetakh@gmail.com9711204141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026