RANDOMIZED CLINICAL TRIAL TO ASSESS THE ROLE OF VITAMIN C IN DEPRESSION

A PROSPECTIVE, RANDOMIZED, OPEN LABEL STUDY TO ASSESS THE ROLE OF VITAMIN C AS AN ADJUVANT TO PAROXETINE IN PHARMACOTHERAPY OF MAJOR DEPRESSIVE DISORDER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019598

Enrollment

Registered

2019-06-10

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: F332- Major depressive disorder, recurrent severe without psychotic features

Interventions

Intervention1: vitamin C: vitamin C 1000 mg/day is added along with standard treatment for 3 months of duration Control Intervention1: Paroxetine: Paroxetine upto 50 mg/day is given to both arm as sta

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed cases of major depressive disorder according to ICD-10 visiting psychiatry OPD. 2.Both male and female patients between the ages of 18-65 years. 3.Patients willing to join the study after giving the informed consent

Exclusion criteria

Exclusion criteria: 1.Patient not willing to give consent for the study. 2.Patients with any organic cause of depression. 3.Any major comorbidities like cardiovascular, renal and hepatic diseases. 4.Any other psychiatric comorbidities. 5.Special physiological conditions like pregnancy, and lactation. 6.Patients using drugs that may interact with Vitamin C like-bishydroxycoumarin and with Proxetine like- thioridazine, pimozide, tamoxifen, warfarin, NSAIDs, alcohol, tryptophan, monoamine oxidase inhibitors like- linezolid and intravenous methylene blue, triptans, lithium, fentanyl, tramadol, cimetidine, other SSRIs and SNRIs, phenobarbital, phenytoin, imipramine, risperidone and any other potential drug interaction.

Design outcomes

Primary

Measure	Time frame
Primary objective is to compare the effect of Paroxetine given along with Vitamin C and Paroxetine given alone.Timepoint: 3 months	—

Secondary

Measure	Time frame
Secondary objectives are, 1.To evaluate the safety profile of Vitamin C given along with Paroxetine. 2.To assess the prevalence of Vitamin C deficiency in the target population. 3.To assess the socio-demographic profile of patients of Major Depressive Disorder. 4.To assess any variation in response to Vitamin C co-administration with baseline Vitamin C level status. Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Kohima Aggarwal

Govt. Medical College, Amritsar

navyug69@gmail.com9592958013

Outcome results

None listed

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