GENRAS (GENetics of Response to Agomelatine vs. EScitalopram)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019423-61-AT

Enrollment

Unknown

Registered

2010-09-28

Start date

2010-10-28

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressive disorder

Interventions

Trade Name: CIPRALEX - Filmtabletten 10 mg Product Name: CIPRALEX - Filmtabletten 10 mg Pharmaceutical Form: Tablet INN or Proposed INN: ESCITALOPRAM CAS Number: 0 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.) meets either ICD-10 or DSM-IV criteria for at least moderate severity of depression 2.) age 18-65 years (or older if otherwise healthy and taking no other medication) 3.) male or female 4.) parents of white European ethnicity 5.) inpatients or outpatients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.) family history of bipolar affective disorder or schizophrenia in first-degree relatives 2.) a personal psychiatric history of bipolar affective disorder, schizophrenia, mood incongruent psychotic symptoms, primary substance misuse, or primary organic disease 3.) current treatment with an antipsychotic or a mood stabiliser, or any regular use of medication known to have an effect on mood 4.) pregnant or breast feeding 5.) acute suicidality

Design outcomes

Primary

Measure	Time frame
Main Objective: The objectives of the GENRAS (Genetics of Response to Agomelatine vs. Escitalopram) study can be divided into 3 layers: 1)The proposed research project is the first study focusing on the genetics of antidepressant response to agomelatine 2)The objectives of the second layer of the proposed research are to investigate the function of variants in genes encoding key proteins in serotonin, neurotrophic and glucocorticoid signaling in determining the response to selective serotonin reuptake inhibiting (SSRI) antidepressants. 3)combine the data obtained on antidepressant response to the SSRI escitalopram with the data on SSRI response of the EU funded NEWMEDS consortium. This will be the single biggest sample with defined antidepressant response and will allow adequately powered tests of drug response moderation by polymorphisms in candidate genes, including relatively small effects, and a genome-wide search for any variation with moderately to strong effects on treatment response. ;Secondary Objective: The objectives of the ‘GENRAS – Gene Expression Pilot Study’, will be performed in the context of the GENRAS study (i.e. it is an amendment to GENRAS, investigating a subgroup of 50 subjects), however not focusing on the pharmacogenetics of the two drugs, but on genome-wide gene expression profiling in peripheral blood at baseline and after 12 weeks of antidepressant treatment, thus providing information on gene expression changes in MDD patients responding/not responding to treatment.;Primary end point(s): the genetics of antidepressant response to agomelatine and escitalopram	—

Measure

Time frame

Main Objective: The objectives of the GENRAS (Genetics of Response to Agomelatine vs. Escitalopram) study can be divided into 3 layers: 1)The proposed research project is the first study focusing on the genetics of antidepressant response to agomelatine 2)The objectives of the second layer of the proposed research are to investigate the function of variants in genes encoding key proteins in serotonin, neurotrophic and glucocorticoid signaling in determining the response to selective serotonin reuptake inhibiting (SSRI) antidepressants. 3)combine the data obtained on antidepressant response to the SSRI escitalopram with the data on SSRI response of the EU funded NEWMEDS consortium. This will be the single biggest sample with defined antidepressant response and will allow adequately powered tests of drug response moderation by polymorphisms in candidate genes, including relatively small effects, and a genome-wide search for any variation with moderately to strong effects on treatment response. ;Secondary Objective: The objectives of the ‘GENRAS – Gene Expression Pilot Study’, will be performed in the context of the GENRAS study (i.e. it is an amendment to GENRAS, investigating a subgroup of 50 subjects), however not focusing on the pharmacogenetics of the two drugs, but on genome-wide gene expression profiling in peripheral blood at baseline and after 12 weeks of antidepressant treatment, thus providing information on gene expression changes in MDD patients responding/not responding to treatment.;Primary end point(s): the genetics of antidepressant response to agomelatine and escitalopram

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026