Investigation of Genetic Predictors of the Response to Selective Serotonin Re-uptake Inhibitors (SSRI) Treatment

NCT03927950 | Completed Phase 4 Results DMC

• 3 other identifiers: 2007-002649-197043SF0180125s08
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depression

Keywords

Treatment efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg's Depression Rating Scale

  Ten-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 60. The lowest possible score on the scale represents "the lack of any depressive symptoms" and the highest score represents the "severe depressive symptoms".

  the results are for a single time point (12 weeks)

Secondary Outcomes (1)

• Hamilton Rating Scale for Depression

  The outcome was measured at the week 12

Study Arms (1)

Escitalopram bupropion open-label

EXPERIMENTAL

No comparator

Drug: escitalopram; Drug: bupropion

Interventions

escitalopram DRUG

escitalopram 10-20mg per day 12 weeks

Also known as: Cipralex

Escitalopram bupropion open-label

bupropion DRUG

bupropion 150-300mg per day 6 weeks

Also known as: Wellbutrin

Escitalopram bupropion open-label

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• Diagnosis according to 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

You may not qualify if:

• 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 or bupropion

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Department of Psychiatry, University of Tartu

Tartu, 50417, Estonia

Location

Related Links

• State Agency of Medicines
• Department of Psychiatry
• University of Tartu

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide; Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones

Results Point of Contact

• Title: Eduard Maron
• Organization: Department of Psychiatry, University of Tartu

eduard.maron@kliinikum.ee

+3727318812

Study Officials

• Eduard Maron, MD, PhD

  Department of Psychiatry, University of Tartu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: April 25, 2019
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 25, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)