Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HolsboerMaschmeyer NeuroChemie GmbH
• Collaborator: Max-Planck-Institute of Psychiatry
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Antidepressive Agents; Citalopram; Dexetimide; Nortriptyline; Paroxetine; Sertraline; Trimipramine; Venlafaxine Hydrochloride

Criteria

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