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Trial registered on ANZCTR


Registration number
ACTRN12609000295246
Ethics application status
Approved
Date submitted
28/04/2009
Date registered
18/05/2009
Date last updated
18/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of Genetic Predictors of the Response to Selective Serotonin Re-Uptake Inhibitors Treatment
Scientific title
Investigation of Genetic Predictors of the Response to Selective Serotonin Re-Uptake Inhibitors (SSRI) Treatment in individuals suffering from major depression
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 4684 0
Antidepressant 4685 0
Treatment prediction 4686 0
Condition category
Condition code
Mental Health 4997 4997 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
escitalopram in doses 10-20mg per day, during 12 weeks, oral administration
Intervention code [1] 4446 0
Prevention
Intervention code [2] 4447 0
Early detection / Screening
Intervention code [3] 4448 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5840 0
Montgomery-Asberg's Depression Rating Scale (MADRS) (remission score < 12)
The genotypic frequencies of serotonin transporter gene were compared between remitters and non-remitters to escitalopram medication. Additionally, the mean change on the MADRS scale was compared between serotonin transporter genotypes at week 12 of escitalopram medication.
Timepoint [1] 5840 0
The primary outcome was measured at the following time points: week 0, 2, 4, 6, 8, 10 and 12
Secondary outcome [1] 241850 0
Hamilton Rating Scale for Depression (HRSD) (remission score < 8)
The genotypic frequencies of serotonin transporter gene were compared between remitters and non-remitters to escitalopram medication. Additionally, the mean change on the HRDS scale was compared between serotonin transporter genotypes at week 12 of escitalopram medication.
Timepoint [1] 241850 0
The secondary outcome was measured at the following time points: week 0, 2, 4, 6, 8, 10 and 12

Eligibility
Key inclusion criteria
Both genders
Major Depression diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
At severity of depression of at least moderate as indicated by a Montgomery-Asberg's Depression Rating Scale (MADRS) total score of 22 or higher
Only secondary current comorbid anxiety disorder
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bipolar disorder
Psychotic disorder or features
Current eating disorders
Mental retardation
Any pervasive developmental disorder or cognitive disorder
Alcohol or drug abuse-related disorders within 12 months prior to baseline
Acute infections, neurological or any other unstable general disorders, serious suicide risk, formal behaviour therapy, or systematic psychotherapy, pregnancy or breastfeeding
A history of hypersensitivity or non-response to escitalopram

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1742 0
Estonia
State/province [1] 1742 0

Funding & Sponsors
Funding source category [1] 4866 0
University
Name [1] 4866 0
Tartu University
Address [1] 4866 0
Raja 31, 50417, Tartu
Country [1] 4866 0
Estonia
Primary sponsor type
University
Name
Tartu University
Address
Raja 31, 50417, Tartu
Country
Estonia
Secondary sponsor category [1] 4402 0
None
Name [1] 4402 0
Address [1] 4402 0
Country [1] 4402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6928 0
Board Name: Estonian State Agency of Medicines
Ethics committee address [1] 6928 0
Nooruse 1, 50411, Tartu
Ethics committee country [1] 6928 0
Estonia
Date submitted for ethics approval [1] 6928 0
Approval date [1] 6928 0
01/01/2007
Ethics approval number [1] 6928 0
2007-002649-19

Summary
Brief summary
The antidepressant medications are among the most commonly prescribed pharmacological agents in patients with mood and anxiety disorder. Despite recent advances in antidepressant pharmacotherapy, there is a pressing need for substantial optimization and improvment of outcome of pharmacotherapy of psychiatric disorders by providing individualized and science-based treatment guidelines. Besides it is rather difficult in clinical practice to predict, which patient will response to a certain pharmacological treatment well and which one less so. Putative predictors of response to antidepressant include demographic and clinical characteristics, personality traits, biological markers and psychophysiological features. Recently the research studies shown that divergences in antidepressant efficacy may be related to genetic variations of patients. The pharmacogenetic studies have multiplied in recent decade due to the impact that such studies may have in everyday clinical practice once reliable predictors could be identified. The pharmacogenetic research using new deoxyribonucleic acid (DNA) microarray-based technology can reasonably be expected to contribute to the prediction of likelihood of treatment response and risk of development of adverse side effects in individual patients in case of antidepressant treatment. By reducing costly treatment failures and the likelihood of serious adverse events, pharmacogenetic testing may help to improve the treatment possibilities for chronic diseases, reduce the burden prescription drug costs, and lower the costs of drug development. The further detailed investigation of peripheral gene expression profiles may help to identify responsible genes that underlie the process of development of affective disorders and open novel horizons for understanding molecular mechanisms of psychopharmacological treatment.
Trial website
Trial related presentations / publications
Maron E, Tammiste A, Kallassalu K, Eller T, Vasar V, Nutt DJ, Metspalu A.
Serotonin transporter promoter region polymorphisms do not influence treatment
response to escitalopram in patients with major depression. Eur
Neuropsychopharmacol. 2009 Mar 7. [Epub ahead of print] PubMed PMID: 19272758.
Public notes

Contacts
Principal investigator
Name 29541 0
Address 29541 0
Country 29541 0
Phone 29541 0
Fax 29541 0
Email 29541 0
Contact person for public queries
Name 12788 0
Eduard Maron
Address 12788 0
Raja 31, 50417, Tartu
Country 12788 0
Estonia
Phone 12788 0
+3727318812
Fax 12788 0
Email 12788 0
eduard.maron@kliinikum.ee
Contact person for scientific queries
Name 3716 0
Eduard Maron
Address 3716 0
Raja 31, 50417, Tartu
Country 3716 0
Estonia
Phone 3716 0
+3727318812
Fax 3716 0
Email 3716 0
eduard.maron@kliinikum.ee

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary