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L-Theanine as an adjuvant therapy for chronic schizophrenia

L-Theanine as an adjuvant therapy added to Risperidone for the treatment of patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N133
Enrollment
50
Registered
2020-12-12
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: Risperidone (Johnson co. Belgium) 2 mg, three times/day + L-Theanine (Institute of Medicinal Plants) 400 mg everyday for 8 weeks. Intervention 2: Control group: Ri

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Diagnosis of schizophrenia based on DSM-5. Minimum score of 60 based on PANSS. Age range: 18-55 years. At least, 2 years have passed since the onset of the disorder.

Exclusion criteria

Exclusion criteria: Diagnosis of another disorder in axis II. Existence of a significant neurological or organic disease. IQ less than 70 based on interviewer clinical suspicion. Substance/drug dependence during the last 6 months (except nicotine and caffeine). Use of antipsychotics during past 1 week or long-term antipsychotics during past 1 month. Receiving ECT during the last 2 weeks. Abnormal endocrine activity. Abnormal kidney and liver function. History of trombosis and embolia. History of abnormal bleeding.

Design outcomes

Primary

MeasureTime frame
Severity of schizophrenia. Timepoint: Baseline and weeks 4 and 8. Method of measurement: By Positive and Negative Syndrome Scale (PANSS).

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 10, 2026