Changes in plasma and platelet Brain-Derived Neurotrophic Factor (BDNF) levels induced by S-citalopram in major depression

ISRCTN	ISRCTN11216093
DOI	https://doi.org/10.1186/ISRCTN11216093
Protocol serial number	1
Sponsor	Hospital Clinic of Barcelona (Hospital Clínic de Barcelona) (Spain)
Funder	Hospital Clinic of Barcelona (Beca fi de residència Hospital Clínica) (Spain) - Grant

Submission date: 17/05/2010
Registration date: 23/06/2010
Last edited: 23/06/2010

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Montserrat Serra
Scientific

Canigó 51, 6B
Vic
08500
Spain

Study information

Primary study design	Interventional
Study design	Longitudinal controlled study for 6 months
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Utility of serum and platelet levels of Brain- Derived Neurotrofic Factor (BDNF) like biological marker of treatment response in major depression: a longitudinal controlled trial
Study acronym	BDNF
Study objectives	1. BDNF levels in depressed patients are lower than in healthy controls in platelet poor plasma and in platelets 2. 8 and 24 weeks treatment with S-citalopram normalize BDNF levels to be similar to healthy controls
Ethics approval(s)	The Ethics Committee of the Hospital Clinic of Barcelona approved in March 2005
Health condition(s) or problem(s) studied	Major depression
Intervention	Patients group: After the baseline assessments and baseline blood samples were obtained, all patients were given S-citalopram orally as an antidepressant therapy. Beginning with 5 mg/day for 4 days, and increased to 10 mg/day in the fifth day. In the following visits, the psychiatrist increased the doses as required up to a maximum of 40 mg/day. We used elevated doses based on severity of clinical depression and on personal experience. One doses per day. The duration of follow-up was 6 months. Healthy controls: Assessments at baseline and no treatment.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	S-citalopram
Primary outcome measure(s)	BDNF levels in platelets and plasma, measured at baseline, 8 and 24 weeks of treatment in the patient group, once in the control group
Key secondary outcome measure(s)	1. Severity of depression was assessed using the 17-item Hamilton Depression Rating Scale (HDRS) 2. Cognitive performance, assessed by: 2.1. Wechsler Adult Intelligence Scale (WAIS-III): Vocabulary, Buckets of Kohs, numerical key similitudes 2.2. Wechsler Memory Scale (WMS-III): Digits, Verbal Memory I, Verbal Memory II 2.3. Train Making Test (TMT) part A and B 2.4. Auditory Verbal Learning Test (AVLT de Rey) (Rey 1964) 2.5. Stroop Color and Word Test 2.6. Wisconsin Card Sorting Test (WCST) 3. Quality of life scales: 3.1. Social Adaptation Self-evaluation Scalen (SASS) 3.2. Perceived Stress Scale (PSS) 3.3. Quality of Life in Depression Scale (QLDS) 4. Personality, assessed by Eysenck Personality Questionnaire (EPQ) Clinical assessments were conducted at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks of treatment, once in the control group.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	32
Key inclusion criteria	1. Patient group: 1.1. Patients suffering from a current major depressive episode, single episode or recurrent, diagnosed according to Diagnostic and Statistical Manual for Mental Disorders Criteria 1.2. A 17-item Hamilton Depression Rating Scale (HDRS) total score of 18 or higher. 1.3. Aged between 18 and 65 years 2. Control group: 2.1. Healthy subjects with no history of chronic physical illness, substance abuse or mental diseases and not taking regular medications in the last month were recruited 2.2. Free of chronic and acute physical illness within the 2 weeks before the study 2.3. Aged between 18 and 65 years 3. Written information was given and written informed consent was obtained from each patient to participate
Key exclusion criteria	1. Patient group: 1.1. Presence of other major axis I disorders, including schizophrenia, bipolar disorders, anxiety disorders, substance-related disorders and eating disorders 1.2. Presence of any acute physical disorders and/or exposure to any psychotropic drugs in the last month 2. Control group 2.1. History of chronic physical illness, substance abuse or mental diseases or taking regular medications in the last month 2.2. Free of chronic and acute physical illness within the 2 weeks before the study
Date of first enrolment	01/07/2005
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Spain

Study participating centre

Canigó 51, 6B

Vic
08500
Spain

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes