Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
NCT ID: NCT02237937
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2011-09-30
2014-12-31
Brief Summary
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Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DOUBLE
Study Groups
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Normal dosage
Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
* paroxetine \< 40 mg/d
* sertraline \< 100 mg/d
* citalopram \< 40 mg/d
* escitalopram \< 20 mg/d
* venlafaxine \< 225 mg/d
* amitriptyline \< 150 mg/d
* amitriptylinoxide \< 150 mg/d
* nortriptyline \< 150 mg/d
* trimipramine \< 150 mg/d
Paroxetine
Sertraline
Citalopram
Venlafaxine
Amitriptyline
Escitalopram
Amitriptylinoxide
Nortriptyline
Trimipramine
High dosage
Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
* paroxetine \< 80 mg/d
* sertraline \< 200 mg/d
* citalopram \< 80 mg/d
* escitalopram \< 40 mg/d
* venlafaxine \< 450 mg/d
* amitriptyline \< 300 mg/d
* amitriptylinoxide \< 300 mg/d
* nortriptyline \< 300 mg/d
* trimipramine \< 300 mg/d
Paroxetine
Sertraline
Citalopram
Venlafaxine
Amitriptyline
Escitalopram
Amitriptylinoxide
Nortriptyline
Trimipramine
Interventions
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Paroxetine
Sertraline
Citalopram
Venlafaxine
Amitriptyline
Escitalopram
Amitriptylinoxide
Nortriptyline
Trimipramine
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 80 years
* Inpatients with a DSM-IV diagnosis of Major Depression
* single episode or recurrent
* moderate to severe intensity
* without psychotic features
* Inpatients with a DSM-IV diagnosis of bipolar disorder I or II
* current episode with depressive symptoms
* moderate to severe intensity
* without psychotic features
* HAM-D score at the time of inclusion in the study ≥ 14
* Patient has already been adjusted to one of the following antidepressants in a dose which is still under the defined normal-dose:
* paroxetine \< 40 mg/d
* sertraline \< 100 mg/d
* citalopram \< 40 mg/d
* escitalopram \< 20 mg/d
* venlafaxine \< 225 mg/d
* amitriptyline \< 150 mg/d
* amitriptylinoxide \< 150 mg/d
* nortriptyline \< 150 mg/d
* trimipramine \< 150 mg/d
Exclusion Criteria
* Acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or delirium
* Current alcohol dependence, or dependencies from other psychotropic substances
* Severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, Parkinson, dementia)
* Patients incapable of giving informed consent
* Pregnant or breast-feeding women
* Women of reproductive age without effective contraception
* Simultaneous participation in other clinical trials or participation in an other clinical trial within 6 weeks before the start of the study
* Hypersensitivity to the study medication or to one of the ingredients of the medication
* Simultaneous treatment with another antidepressant besides study medication (exception: trazodone up to 75 mg/d, mirtazapine up to 15 mg/d, trimipramine up to 50 mg/d)
* Simultaneous treatment with mood stabilizers or neuroleptic drugs (exception: quetiapine up to 50 mg/d, olanzapine up to 5 mg/d)
18 Years
79 Years
ALL
Yes
Sponsors
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Max-Planck-Institute of Psychiatry
OTHER
HolsboerMaschmeyer NeuroChemie GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Florian Holsboer, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Max-Planck-Institute of Psychiatry
Locations
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Max Planck Institute of Psychiatry
Munich, Bavaria, Germany
Countries
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Central Contacts
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Other Identifiers
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2011-003190-29
Identifier Type: -
Identifier Source: org_study_id
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