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 |
| Secondary identifying numbers | 1 |
- 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
Scientific
Canigó 51, 6B
Vic
08500
Spain
Study information
| Study design | Longitudinal controlled study for 6 months |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please contact Mrs Montserrat Serra Millàs [serra2mont@yahoo.es] to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | S-citalopram |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 32 participants (18 depressive patients and 14 healthy controls) |
| 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
08500
Spain
Sponsor information
Hospital Clinic of Barcelona (Hospital Clínic de Barcelona) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Villarroel 170
Barcelona
08036
Spain
| Website | http://www.hospitalclinic.org |
|---|---|
"ROR" |
https://ror.org/02a2kzf50 |
Funders
Funder type
Hospital/treatment centre
Hospital Clinic of Barcelona (Beca fi de residència Hospital Clínica) (Spain) - Grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
