Investigation of Genetic Predictors of the Response to Selective Serotonin Re-uptake Inhibitors (SSRI) Treatment
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Intervention: escitalopram; bupropion
Intervention description: escitalopram 10-20mg per day 12 weeks; bupropion 150-300mg per day 6 weeks
Intervention MeSH terms: Bupropion; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Treatment efficacy; Safety

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