Status:
UNKNOWN
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Lead Sponsor:
HolsboerMaschmeyer NeuroChemie GmbH
Collaborating Sponsors:
Max-Planck-Institute of Psychiatry
Conditions:
Major Depression
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein,...
Eligibility Criteria
Inclusion
- Male and female patients
- 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
- Acute suicidality (HAM-D Item 3 score \> 2)
- 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)
- Exclusion criteria of the study medication
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02237937
Start Date
September 1 2011
End Date
December 1 2014
Last Update
September 12 2014
Active Locations (1)
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1
Max Planck Institute of Psychiatry
Munich, Bavaria, Germany, 80804