Plain English Summary
Background and study aims
Depression is a recurrent illness associated with high death rate. Most of the patients do not respond to antidepressants (AD) (drugs used to treat depression/sadness). There is a clear need for methods that select the right treatment for the right patient. Previous studies identified a number of factors associated with successful treatment with antidepressants. Our goal is to compare those factors with standard antidepressants and find out how good these factors are in predicting the outcome of the treatment in patients suffering from depression.
Who can participate?
The study aims to recruit 40 patients with depression (aged between 18-65 years) who failed to respond to at least one antidepressant treatment.
What does the study involve?
Over a period of two years, participants will be invited to take part in the study. It will involve 6-week treatment with standard antidepressants (SSRI) that are usually used. The type of treatment will be decided by a specialist based on the condition of the patient. This will be discussed with the patient as usual. The patient will be invited to give blood sample before start of the new treatment and at week 1 and at the end of study. We will also record the brain activity using electroencephalogram (EEG).
What are the possible benefits and risks of participating?
There will be no immediate direct benefits to those taking part. There will not be considerable risks compared to regular treatment.
Where is the study run from?
The study will be carried out in Prague Psychiatric Center, Czech Republic.
When is the study starting and how long is it expected to run for?
The study starts in May 2013 and its clinical part will finish probably in June 2015. The participation of patients will last for 6 weeks.
Who is funding the study?
This study is funded by Internal Grant Agency of the Ministry of Health, Czech Republic.
Who is the main contact?
Dr Martin Bares
bares@pcp.lf3.cuni.cz
Trial website
Contact information
Type
Scientific
Primary contact
Dr Martin Bares
ORCID ID
Contact details
Prague Psychiatric Center
Ustavni 91
Prague 8 - Bohnice
181 02
Czech Republic
-
bares@pcp.lf3.cuni.cz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IGA MZ CR NT 14287
Study information
Scientific title
The predictors of response to antidepressant treatment in patients with resistant depression-an integrative approach - open-label, prospective study
Acronym
Study hypothesis
The aim of our project is to compare efficacy of a decrease of QEEG prefrontal cordance, an increase of brain-derived neurotrophic factor in plasma (pBDNF) and serum brain-derived neurotrophic factor (sBDNF) all after 1st week of treatment, reduction of depressive symptomatology at week 1 and 2 and baseline values of LDAEP in the prediction of response to 6-week treatment with selective serotonin reuptake inhibitors (SSRI) in patients with resistant depression.
The next goal of project is to evaluate predictive ability of combination of above mentioned predictors and to postulate combined predictive model.
Ethics approval
The study was approved by Ethic Committee of Prague Psychiatric Center on the 20th June 2012 - reference number 69/12
Study design
Interventional non-randomized single-center open-label study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet [only available in Czech language]
Condition
More than one previous unsuccessful antidepressant trial lasting 4 or more weeks in the current episode of depression
Intervention
Subjects will be treated with selective serotonin reuptake inhibitors. Specific antidepressant will be chosen by attending psychiatrist according to clinical judgement and with regard to the history of previous treatment. Antidepressants will be used in the dose cited in Summary of Products. The total duration of treatment will be 6 weeks. Concomitant treatment (hypnotics and hydroxyzine) will be used in cases of prominent severe anxiety and insomnia. Depressive symptoms and overall clinical status will be assessed at baseline at week 1, 2, 4 and at the end of study using the MADRS Montgomery-Åsberg Depression Rating Scale, QIDS-SR (Quick Inventory of Depressive symptoms-SR) and CGI (Clinical Global Impression).
EEG (cordance calculations) will be recorded at baseline and after 1week of treatment. Measurement of BDNF: The blood samples will be collected at baseline, week 1 and at the end of study in patient´s non-fasting state, between 7.00 and 9.00 a.m.
Response to treatment is defined as a reduction of MADRS score higher or equal to 50% at the end of study.
Intervention type
Drug
Phase
Not Specified
Drug names
Serotonin reuptake inhibitors
Primary outcome measure
The ratio of occurrence of a priory defined predictors in responders and non-responders:
1. The reduction of MADRS score ≥20% at week 1 compared to baseline
2. The reduction of MADRS score ≥20% at week 2 compared to baseline
3. Reduction of prefrontal cordance value at week 1 compared to baseline,
4. The increase of pBDNF at week 1 compared to baseline
5. The increase of sBDNF at week 1 compared to baseline
Secondary outcome measures
The correlation of predictors value change at week 1 or 2 and the change of MADRS score at the end of study.
Overall trial start date
01/05/2013
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients suffering from Major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of the American Psychiatric Association-IV. revision (DSM-IV) criteria, confirmed using The Mini-International Neuropsychiatric Interview - M.I.N.I., Czech version 5.0.0.
2. Patients fulfilling at least Stage I (≥1 previous, unsuccessful, adequate, antidepressant treatment) criteria for resistant depression according to Thase and Rush.
3. The mental ability to understand and sign Informed Consent Form.
4. The score in the Montgomery and Åsberg Rating Scale (MADRS) ≥25 and the score in Clinical Global Impression (CGI)≥4.
5. Inpatients.
6. Age between 18 and 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Contraindications of treatment with selective serotonin reuptake inhibitors (SSRIs) (citalopram, escitalopram, fluoxetine, fluvoxamine, sertraline, paroxetine) according to Summary of Product (SPC)
2. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to the study
3. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders etc.) that could be associated with depression due to somatic disease.
4. Patients treated with electroconvulsive therapy less than 3 month before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment which can strongly affect EEG.
5. Patients who were treated unsuccessfully with more than one SSRIs during index episode.
Recruitment start date
01/05/2013
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Czech Republic
Trial participating centre
Prague Psychiatric Center
Prague 8 - Bohnice
181 02
Czech Republic
Sponsor information
Organisation
Ministry of Health (Czech Republic) - Internal Grant Agency
Sponsor details
Palackého nám. 4
Prague
181 02
Czech Republic
-
mzcr@mzcr.cz
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Internal Grant Agency of Ministry of Health of Czech Republic grant ref: IGA MZ CR NT 14287
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
Basic results (scientific)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27660994 (added 22/01/2019)