MedPath

Does Co-enzyme Q10 supplementation in patients with depression improve their symptoms

Phase 3
Conditions
Health Condition 1: F30-F39- Mood [affective] disorders
Registration Number
CTRI/2023/04/051582
Lead Sponsor
AIIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. All adult patients of either sex aged 18-65 years with clinical diagnosis of Major Depressive Disorder as per DSM-5 criteria.

2. Patients on stable dose (no change in dose) of anti-depressants for 4 weeks.

3. Patients willing to participate and give consent.

Exclusion Criteria

1. Patients with comorbid psychiatric or neurological disorders such as anxiety disorder, schizophrenia, current state of psychosis, epilepsy and substance use disorder

2. Patient currently having suicidal ideas or history of suicidal plan/attempt.

ï?§ Pregnancy or lactation or expecting to get pregnant during the treatment.

ï?§ Patient on concomitant warfarin therapy, anti-hypertensive drugs or statins.

ï?§ Patients with chronic liver disease.

ï?§ Poor adherence to medications.

ï?§ Patient not willing to give consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ï?§ To evaluate the effect of add on COQ10 on depressive symptoms as assessed by MADRS in patients with Major depressive disorder after 4 weeks of therapy.Timepoint: ï?§ To evaluate the effect of add on COQ10 on depressive symptoms as assessed by MADRS in patients with Major depressive disorder after 4 weeks of therapy.
Secondary Outcome Measures
NameTimeMethod
1. To evaluate the change in serum IDO and serum BDNF after 4 weeks of add on CoQ10 therapy. <br/ ><br>2. To evaluate the change in cognition score after 4 weeks of add-on CoQ10 therapy. <br/ ><br>3. To evaluate the safety of add on COQ10. <br/ ><br>Timepoint: At baseline and 4 weeks
© Copyright 2025. All Rights Reserved by MedPath