Study on Antidepressant Effect of Two Antidepressants Amitriptyline and Fluoxetine in patients with depression

Comparative study on Efficacy and safety profile of Amitriptyline and Fluoxetine in patients with depression

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/11/010443

Enrollment

Registered

2017-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- depression

Interventions

Control Intervention1: Fluoxetine: Cap. Fluoxetine (20 â?? 40 mg /day)P.o 40 patients- 16 weeks Control Intervention2: Amitriptyline: Tab.Amitriptyline (25â??150mg/day) P.O 40 patients-16 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1.19years â?? 60 years of age both sex 2.newly diagnosed patients with clinical depression (moderate to severe ) according to ICD 10 criteria 3. Major depressive disorder patients.

Exclusion criteria

Exclusion criteria: 1.Less than 19 years 2. more than 60 years. 3.Pregnant and Lactating mothers. 4.Patients with h/o Cardiac , Hepatic and renal disease ,Co morbid illness and terminal illness. Known case of Pulmonary Tuberculosis, HIV/AIDS, Leprosy, Hypothyroidism. Patients with history of hypersensitive reaction to Amitriptyline and Fluoxetine. Patients on any other investigational drugs. Depression with psychosis, bipolar depression .

Design outcomes

Primary

Measure	Time frame
17- point HAM-D (Hamilton Depression) rating scaleTimepoint: 4 months	—

Secondary

Measure	Time frame
17- point HAM-D (Hamilton Depression) rating scaleTimepoint: 6 months	—

Countries

India

Contacts

Public Contacts vasanth

professor of pharmacology

vsarojini2010@gmail.com9442146541

Outcome results

None listed

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