Condition category
Mental and Behavioural Disorders
Date applied
17/05/2010
Date assigned
23/06/2010
Last edited
23/06/2010
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

Mrs Montserrat Serra

ORCID ID

Contact details

Canigó 51
6B
Vic
08500
Spain

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

http://www.hospitalclinic.org

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

Publication citations

Additional files

Editorial Notes