Clinical trial NCT02237937: Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Official title: Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression
Keywords: Depression, Affective Disorder
Lead sponsor: HolsboerMaschmeyer NeuroChemie GmbH
Sponsor class: INDUSTRY
Collaborators: name: Max-Planck-Institute of Psychiatry
First posted: 2014-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: 25% improvement in the HAM-D
timeFrame: after 28 days of treatment
Secondary outcomes:
measure: side effects
timeFrame: after 28 days of treatment
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
state: Bavaria
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Florian Holsboer, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: