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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02237937
• Other study ID #: 2011-003190-29
• Status: Recruiting
• Phase: Phase 4
• First received: August 26, 2013
• Last updated: September 9, 2014
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: HolsboerMaschmeyer NeuroChemie GmbH
• Contact: Barbara Breitenstein, MSc
• Phone: 0049 89 30622
• Email: barbara_breitenstein[@]mpipsykl.mpg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Paroxetine

• Sertraline

• Citalopram

• Venlafaxine

• Amitriptyline

• Escitalopram

• Amitriptylinoxide

• Nortriptyline

• Trimipramine

Locations

Country	Name	City	State
Germany	Max Planck Institute of Psychiatry	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
HolsboerMaschmeyer NeuroChemie GmbH	Max-Planck-Institute of Psychiatry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25% improvement in the HAM-D	Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)	after 28 days of treatment	No
Secondary	side effects	UKU side effect scale, AMDP side effect scale	after 28 days of treatment	No