Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Phase 4
- Conditions
- Major Depression
- Interventions
- Registration Number
- NCT02237937
- Lead Sponsor
- HolsboerMaschmeyer NeuroChemie GmbH
- 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, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Normal dosage Amitriptylinoxide 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 Normal dosage Amitriptyline 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 Normal dosage Escitalopram 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 Normal dosage Paroxetine 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 Normal dosage Sertraline 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 Normal dosage Citalopram 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 Normal dosage Venlafaxine 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 Normal dosage Trimipramine 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 High dosage Sertraline 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 High dosage Paroxetine 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 High dosage Citalopram 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 High dosage Venlafaxine 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 High dosage Amitriptyline 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 High dosage Escitalopram 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 High dosage Amitriptylinoxide 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 High dosage Trimipramine 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 Normal dosage Nortriptyline 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 High dosage Nortriptyline 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
- Primary Outcome Measures
Name Time Method 25% improvement in the HAM-D after 28 days of treatment Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)
- Secondary Outcome Measures
Name Time Method side effects after 28 days of treatment UKU side effect scale, AMDP side effect scale
Trial Locations
- Locations (1)
Max Planck Institute of Psychiatry
🇩🇪Munich, Bavaria, Germany