To Investigate the anti-proliferative and anti-cancer potential of Moclobemide (an anti-depression drug) in castration resistant prostate cancer.

Randomized double blind placebo-controlled clinical trial â?? an exploratory study to investigate the efficacy of moclobemide as an add-on treatment in castration-resistant prostate cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048893

Enrollment

Registered

2023-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Trima 150mg (Moclobemide): Drug will be purchased from local market (Trima 150mg) in bulk Intervention2: Moclobemide 150 mg: Moclobemide will be provided free of cost to patients on enr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age>=18 years 2. Castration-resistant prostate cancer patients (CRPC): Disease progression despite androgen-deprivation therapy (ADT) and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen (PSA), progression of pre-existing disease, or appearance of new metastases (Ga-68-PSMA PET/CT Scan) and characterized by low levels of testosterone (

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to participate 2. Active psychiatric illnesses that would limit compliance with protocol requirements 3. Patients taking tricyclic/tetracyclic antidepressants or selective serotonin reuptake inhibitors, or serotonin norepinephrine reuptake inhibitors or conventional monoamine oxidase inhibitors or thioridazine or dextromethorphan or bupropion or triptans or tramadol or meperidine or selegiline or any antipsychotic drugs or sympathomimetic drugs or linezolid 4. Patients with connective tissue disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis and other autoimmune disorders 5. Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal 6. Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal 7. Patients with congestive cardiac failure, severe or unstable angina or thyrotoxicosis 8. Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy 9. Administration of any other investigational therapeutic agent within 30 days of screening 10. Prior radiation therapy completed 11. Any "currently active" second malignancy 12. Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated 13. Patients taking strong CYP2D6, CYP2C19 and CYP3A4 inducer or inhibitor, available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org) 14. Pheochromocytoma 15. Carcinoid Syndrome 16. Angle-closure glaucoma

Design outcomes

Secondary

Measure	Time frame
1. Radiological progression-free survival 2. CTCs count (decrease from baseline)Timepoint: Ga-68-PSMA PET/CT scan and CTCs titre (at baseline and at 12 months of follow-up)	—

Primary

Measure	Time frame
Tumor response rate measured using serum PSA levelsTimepoint: Tumor response rate will be determined by monitoring PSA levels (at baseline, 3, 6, 9 and 12 month)	—

Countries

India

Contacts

Public ContactDr Amlesh Seth

AIIMS New Delhi

dsarya16@gmail.com9810210834

Outcome results

None listed

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