Study of lymphocyte neurotransmitter markers in depression and anxiety

ISRCTN	ISRCTN06123818
DOI	https://doi.org/10.1186/ISRCTN06123818
Protocol serial number	FONACIT G-1387
Sponsor	Venezuelan Institute of Scientific Investigations (Instituto Venezolano de Investigaciones Científicas) (Venezuela)
Funders	The National Fund of Scientific Technology and Innovation (FONACIT; ref: G-1387) (Venezuela), The Venezuelan Institute of Scientific Investigations (IVIC) (Venezuela)

Submission date: 31/01/2008
Registration date: 27/06/2008
Last edited: 11/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lucimey Lima
Scientific

Laboratorio de Neuroquímica
Instituto Venezolano de Investigaciones Científicas
Carretera Panamericana Km 11
Apdo. 21827
Caracas
1020-A
Venezuela

Phone	+58 212 504 1213
Email	llima@ivic.ve

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	5HTSYNT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	fluoxetine and folic acid
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Correlation between response to antidepressant and biochemical measurements
Completion date	29/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	27
Key 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
Key exclusion criteria	1. Pregnancy 2. Surgery 3. Adverse effect to treatments 4. Allergies, infections, inflammation 5. Excessive consumption of coffee, tea, tobacco or alcohol
Date of first enrolment	01/12/2006
Date of final enrolment	29/02/2008

Locations

Countries of recruitment

Venezuela

Study participating centre

Laboratorio de Neuroquímica

Caracas
1020-A
Venezuela

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2008	11/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/06/2019: Publication reference and total final enrolment added.