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Phase 4 N=135 Treatment

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

Major Depression

Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Montgomery-Asberg's Depression Rating Scale — 9.2 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
escitalopram (Drug); bupropion (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Tartu
Primary completion
Jan 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Montgomery-Asberg's Depression Rating Scale
9.2
SECONDARY
Hamilton Rating Scale for Depression
7.2

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.

Eligibility Criteria

Inclusion Criteria

  • 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

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 or bupropion
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03927950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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