Investigation of Genetic Predictors of the Response to Selective Serotonin Re-uptake Inhibitors (SSRI) Treatment
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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 the female and male patients with panic disorder or major
      depression diagnosis according to DSM-IV criteria. Patients will be recruited from the out-
      and inpatients services of the Psychiatric Clinic of the Tartu University Hospital. For the
      detailed assessment of clinical severity of specific disorder and treatment effects the
      disorder-specific rating scales: Montgomery-Asberg's Depression Rating Scale (MADRS),
      Clinical Global Impression scale (CGI) will be used. The adverse effects will be evaluated by
      letting the patients to fill the checklist of side-symptoms. In both patient groups (with
      panic disorder and major depression) an SSRI escitalopram (Cipralex) will be administrated
      for 12 weeks in flexible dose ranging between 10 - 20 mg/per day. At the end of week 12 the
      patients will defined as responders if the decrease in MADRS scores is at least 50% and score
      on the CGI improvement scale is 2 or less. The remitters will defined if the scores are less
      than 12 on the MADRS. Patients who do not meet these criteria will defined as non-responders
      and non-remitters respectively. Depressive patients, showing non-response to escitalopram
      monotherapy will given the combination of 20 mg of escitalopram and 150-300 mg of bupropion
      (Wellbutrin SR) for 6 weeks.
    

Intervention name(s): escitalopram; bupropion
Intervention type(s): Drug; Drug
Intervention description(s): escitalopram 10-20mg per day 12 weeks; bupropion 150-300mg per day 6 weeks
Other intervention name(s): Cipralex; Wellbutrin
Intervention MeSH terms: Bupropion; Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment efficacy; Safety