Condition category
Mental and Behavioural Disorders
Date applied
31/01/2008
Date assigned
27/06/2008
Last edited
22/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucimey Lima

ORCID ID

Contact details

Laboratorio de Neuroquímica
Instituto Venezolano de Investigaciones Científicas
Carretera Panamericana Km 11
Apdo. 21827
Caracas
1020-A
Venezuela
+58 212 504 1213
llima@ivic.ve

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FONACIT G-1387

Study information

Scientific title

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

Acronym

5HTSYNT

Study hypothesis

The administration of folic acid plus the antidepressant fluoxetine to patients with major depression could augment the response to the antidepressant, and also modify the content, the synthesis of serotonin, neurotransmitter and immunomodulator, and the presence of tryptophan hydroxylase in lymphocytes, and then influence functionality

Ethics approval

This trial was part of a project "Nervous System Markers in Lymphocytes of Patients with Major Depression or Generalized Anxiety." This project received approval from three ethics committees:
1. Ethic Committees of the Venezuelan Institute of Scientific Invesgigations (Instituto Venezolano de Investigaciones Científicas; IVIC). Approved in 2000
2. Caracas Hospital (Hospital Vargas de Caracas; VHC). Approved in 2001
3. The National Fund of Scientific Technology and Innovation (FONACIT; http://www.fonacit.gov.ve). Approved in 2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Major depression

Intervention

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:
Study 1: Fluoxetine (oral) 20 mg/day plus placebo (30 participants) vs fluoxetine (oral) 20 mg/day plus omega-3 (oral) 900 mg/day (30 participants)
Study 2: Fluoxetine (oral) 20 mg/day plus placebo (30 participants) vs fluoxetine (oral) 20 mg/day plus folic acid (oral) 10 mg/day (30 participants)

Total number of participants = 30 x 4 = 120

Interventions provided at time of registration:
This trial consists of two studies:
Study 1: Fluoxetine plus placebo (30 participants) vs fluoxetine plus omega-3 (30 participants)
Study 2: Fluoxetine plus placebo (30 participants) vs fluoxetine plus folic acid (30 participants)

Total number of participants = 30 x 4 = 120 participants.

Intervention type

Drug

Phase

Not Specified

Drug names

fluoxetine and folic acid

Primary outcome measures

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 outcome measures

Correlation between response to antidepressant and biochemical measurements

Overall trial start date

01/12/2006

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

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

Recruitment start date

01/12/2006

Recruitment end date

29/02/2008

Locations

Countries of recruitment

Venezuela

Trial participating centre

Laboratorio de Neuroquímica
Caracas
1020-A
Venezuela

Sponsor information

Organisation

Venezuelan Institute of Scientific Investigations (Instituto Venezolano de Investigaciones Científicas) (Venezuela)

Sponsor details

c/o Dr Lucimey Lima
Laboratorio de Neuroquímica
Carretera Panamericana Km 11
Apdo. 21827
Caracas
1020-A
Venezuela
+58 212 504 1213
llima@ivic.ve

Sponsor type

Research organisation

Website

http://www.ivic.ve

Funders

Funder type

Government

Funder name

The National Fund of Scientific Technology and Innovation (FONACIT; ref: G-1387) (Venezuela)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Venezuelan Institute of Scientific Investigations (IVIC) (Venezuela)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes