Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
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, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.

 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.
Inclusion Criteria:

 -  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 Criteria:

 -  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