Skip to content

The Effect of Adjuvant Therapy with Folic Acid and Methylcobalamin on BDNF (Brain-Derived Neurotrophic Factor) Levels and Cognitive Function in Patients with Depression Receiving Fluoxetine Therapy

The Effect of Adjuvant Therapy with Folic Acid and Methylcobalamin on BDNF (Brain-Derived Neurotrophic Factor) Levels and Cognitive Function in Patients with Depression Receiving Fluoxetine Therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250818014
Enrollment
36
Registered
2025-08-18
Start date
2025-05-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Major depressive disorder Depression Folic acid Methylcobalamin Fluoxetine BDNF Cognitive function Antidepressants Neuroplasticity SSRI Vitamin B12

Interventions

Patients in this group will receive standard fluoxetine therapy (20 mg/day) combined with oral folic acid 1 mg/day and methylcobalamin 500 mcg/day for 6 weeks.,Patients in this group will receive stan
Experimental Drug,Active Comparator Drug

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged between 20 and 45 years. 2. Diagnosed with depression based on PPDGJ-III criteria. 3. Currently undergoing treatment with fluoxetine. 4. Minimum education level of junior high school. 5. Willing to participate by providing informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with psychiatric disorders due to organic causes. 2. History of substance abuse within the past year. 3. Presence of chronic illnesses requiring the use of anti-inflammatory drugs, antibiotics, or other supplements. 4. Experiencing severe psychiatric symptoms, such as psychosis.

Design outcomes

Primary

MeasureTime frame
Serum Brain-Derived Neurotrophic Factor (BDNF) level Baseline and 6 weeks after intervention Measured using ELISA from serum samples,Cognitive function score Baseline and 6 weeks after intervention Assessed using Montreal Cognitive Assessment Indonesian Version (MoCA-Ina)

Secondary

MeasureTime frame
Depression severity score Baseline and 6 weeks after intervention Measured using a standardized depression scale (e.g. Hamilton Depression Rating Scale or equivalent),Adverse events Throughout the 6-week study period Monitored by clinician during scheduled visits and patient self-reporting

Countries

Indonesia

Contacts

Public ContactMaria Dianomo

Hasanuddin University

vinta150890@gmail.com6282293326077

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026