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Trial record 14 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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

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ClinicalTrials.gov Identifier: NCT03927950
Recruitment Status : Completed
First Posted : April 25, 2019
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eduard Maron, University of Tartu

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: escitalopram Drug: bupropion Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Genetic Predictors of the Response to SSRI Treatment
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008


Arm Intervention/treatment
Experimental: Escitalopram bupropion open-label
No comparator
Drug: escitalopram
escitalopram 10-20mg per day 12 weeks
Other Name: Cipralex

Drug: bupropion
bupropion 150-300mg per day 6 weeks
Other Name: Wellbutrin




Primary Outcome Measures :
  1. Montgomery-Asberg's Depression Rating Scale [ Time Frame: the results are for a single time point (12 weeks) ]
    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".


Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression [ Time Frame: The outcome was measured at the week 12 ]
    17-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 52. The lowest possible score on the scale represents "the lack of any depressive symptoms" and the highest score represents the "severe depressive symptoms".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927950


Locations
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Estonia
Department of Psychiatry, University of Tartu
Tartu, Estonia, 50417
Sponsors and Collaborators
University of Tartu
Investigators
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Principal Investigator: Eduard Maron, MD, PhD Department of Psychiatry, University of Tartu

Additional Information:
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Responsible Party: Eduard Maron, Department of Psychiatry, University of Tartu
ClinicalTrials.gov Identifier: NCT03927950     History of Changes
Other Study ID Numbers: 2007-002649-19
7043 ( Other Grant/Funding Number: Ministry of Education, Estonia )
SF0180125s08 ( Other Grant/Funding Number: Ministry of Education, Estonia )
First Posted: April 25, 2019    Key Record Dates
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eduard Maron, University of Tartu:
Treatment efficacy
Safety

Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Dopamine Uptake Inhibitors
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Bupropion
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors