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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02237937

Enrollment

Registered

2014-09-12

Start date

2011-09-30

Completion date

2014-12-31

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

Depression, Affective Disorder

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.

Interventions

DRUGParoxetine

DRUGCitalopram

DRUGSertraline

DRUGVenlafaxine

DRUGAmitriptyline

DRUGEscitalopram

DRUGAmitriptylinoxide

DRUGNortriptyline

DRUGTrimipramine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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) *

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
side effects	after 28 days of treatment	UKU side effect scale, AMDP side effect scale

Countries

Germany

Contacts

Primary ContactBarbara Breitenstein, MSc

barbara_breitenstein@mpipsykl.mpg.de0049 89 30622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026