Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
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
Acronym
BDNF
Study hypothesis
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
The Ethics Committee of the Hospital Clinic of Barcelona approved in March 2005
Study design
Longitudinal controlled study for 6 months
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please contact Mrs Montserrat Serra Millàs [serra2mont@yahoo.es] to request a patient information sheet
Condition
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 names
S-citalopram
Primary outcome measures
BDNF levels in platelets and plasma, measured at baseline, 8 and 24 weeks of treatment in the patient group, once in the control group
Secondary outcome measures
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.
Overall trial start date
01/07/2005
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32 participants (18 depressive patients and 14 healthy controls)
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Canigó 51, 6B
Vic
08500
Spain
Sponsor information
Organisation
Hospital Clinic of Barcelona (Hospital Clínic de Barcelona) (Spain)
Sponsor details
Villarroel 170
Barcelona
08036
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Clinic of Barcelona (Beca fi de residència Hospital Clínica) (Spain) - Grant
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