Study of lymphocyte neurotransmitter markers in depression and anxiety

A randomised study on the antidepressive effect of fluoxetine and folic acid, as possible augmenter, and the SYNThesis of serotonin (5-HT) in lymphocytes prior and after treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN06123818

Enrollment

120

Registered

2008-06-27

Start date

2006-12-01

Completion date

Unknown

Last updated

2019-07-01

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

Conditions

Major depression Mental and Behavioural Disorders Depressive episode

Interventions

As of 22/07/2008, information on the dose and route of administration for each drug/supplement were added to the interventions: This trial consists of two studies: Stud

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. 18 to 60 years 3. Major depression episode, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria 4. Without psychotic symptoms 5. Mild and moderate 6. Without risks of suicide 7. Without another psychiatric disorder 8. Without another medical illness 9. Free of pharmacological treatment for one month prior to inclusion into the study

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Surgery 3. Adverse effect to treatments 4. Allergies, infections, inflammation 5. Excessive consumption of coffee, tea, tobacco or alcohol

Design outcomes

Primary

Measure	Time frame
1. Response to differential treatment at 2, 4 and 6 weeks 2. Magnitude of the response at 2, 4 and 6 weeks 3. Biochemical analyses on blood samples at 0 and 6 weeks: 3.1. Neurotransmitters in plasma 3.2. Isolation of lymphocytes 3.3. Neurotransmitters in lymphocytes 3.4. Detection of tryptophan hydroxylase 3.5. Folate levels 3.6. Homocysteine levels 3.7. Vitamin B12 levels 4. In participants who took omega-3, brain-derived neurotrophic factor (BDNF) in serum and lymphocytes will be determined	—

Measure

Time frame

1. Response to differential treatment at 2, 4 and 6 weeks 2. Magnitude of the response at 2, 4 and 6 weeks 3. Biochemical analyses on blood samples at 0 and 6 weeks: 3.1. Neurotransmitters in plasma 3.2. Isolation of lymphocytes 3.3. Neurotransmitters in lymphocytes 3.4. Detection of tryptophan hydroxylase 3.5. Folate levels 3.6. Homocysteine levels 3.7. Vitamin B12 levels 4. In participants who took omega-3, brain-derived neurotrophic factor (BDNF) in serum and lymphocytes will be determined

—

Secondary

Measure	Time frame
Correlation between response to antidepressant and biochemical measurements	—

Countries

Venezuela

Outcome results

None listed

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