Investigation of genetic predictors of the response to SSRI treatment in patients with panic disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002649-19-EE

Enrollment

500

Registered

2009-12-18

Start date

2010-04-07

Completion date

Unknown

Last updated

2015-09-07

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

Conditions

panic disorder

Interventions

Trade Name: Cipralex Product Name: Escitalopram Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To participate in the study, the subjects must be at least 18 years old and give a written informed consent after an oral and written explanation of the study aims and methods. The study sample will include at least 150 female and 150 male patients with PD diagnosis according to DSM-IV criteria with or without comorbid depression. The additional inclusion criteria will be at least moderate clinical severity, suitability to treatment with an SSRI 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: history of other psychiatric disorders, such as organic mental disorders, substance use disorders, psychotic disorders, bipolar disorder; serious somatic diseases; pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigation of genetic predictors of the response to SSRI treatment in patients with panic disorder;Secondary Objective: 1. Collect relevant clinical material at least 150 responders and equal number of non-responders from the Tartu University Hospital. 2. Using Illumina WGA Infinium assay (317K SNPs) perform the association analysis of the responders and non-responders in order to identify up to 10 SNPs with the most significant p values (n=150). 3. Perform the gene expression analysis of the same subjects using the Illumina WG direct hybridization assay with the 48k elements on the array in order to identify the genes with the most altered expression pattern (n=150). 4. Based to obtained data propose a predictive genetic test and find the predictive power using the data from drug responders. 5. This will be validated in the next, prospective study. ;Primary end point(s): For the detailed assessment of clinical severity and treatment effects the disorder-specific rating scales: Panic Disorder Severity Scale (PDSS), Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression scale (CGI) will be used. The positive response to treatment will be defined if decrease in PDSS total score will be at least 50% The adverse effects will be evaluated patient-completed checklist of symptoms.	—

Measure

Time frame

Main Objective: Investigation of genetic predictors of the response to SSRI treatment in patients with panic disorder;Secondary Objective: 1. Collect relevant clinical material at least 150 responders and equal number of non-responders from the Tartu University Hospital. 2. Using Illumina WGA Infinium assay (317K SNPs) perform the association analysis of the responders and non-responders in order to identify up to 10 SNPs with the most significant p values (n=150). 3. Perform the gene expression analysis of the same subjects using the Illumina WG direct hybridization assay with the 48k elements on the array in order to identify the genes with the most altered expression pattern (n=150). 4. Based to obtained data propose a predictive genetic test and find the predictive power using the data from drug responders. 5. This will be validated in the next, prospective study. ;Primary end point(s): For the detailed assessment of clinical severity and treatment effects the disorder-specific rating scales: Panic Disorder Severity Scale (PDSS), Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression scale (CGI) will be used. The positive response to treatment will be defined if decrease in PDSS total score will be at least 50% The adverse effects will be evaluated patient-completed checklist of symptoms.

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Countries

Estonia

Outcome results

None listed

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