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

NCT02237937 | Unknown Phase 4

• 1 other identifier: 2011-003190-29
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Depression, Affective Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• side effects

  after 28 days of treatment

Study Arms (2)

Normal dosage

EXPERIMENTAL

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

Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Amitriptyline; Drug: Escitalopram; Drug: Amitriptylinoxide; Drug: Nortriptyline; Drug: Trimipramine

High dosage

EXPERIMENTAL

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

Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Amitriptyline; Drug: Escitalopram; Drug: Amitriptylinoxide; Drug: Nortriptyline; Drug: Trimipramine

Interventions

Paroxetine DRUG

High dosage; Normal dosage

Sertraline DRUG

High dosage; Normal dosage

Citalopram DRUG

High dosage; Normal dosage

Venlafaxine DRUG

High dosage; Normal dosage

Amitriptyline DRUG

High dosage; Normal dosage

Escitalopram DRUG

High dosage; Normal dosage

Amitriptylinoxide DRUG

High dosage; Normal dosage

Nortriptyline DRUG

High dosage; Normal dosage

Trimipramine DRUG

High dosage; Normal dosage

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HolsboerMaschmeyer NeuroChemie GmbH: lead
• Max-Planck-Institute of Psychiatry: collaborator

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Mood Disorders

Interventions

Paroxetine; Sertraline; Citalopram; Venlafaxine Hydrochloride; Amitriptyline; Escitalopram; amitriptyline N-oxide; Nortriptyline; Trimipramine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Dibenzocycloheptenes; Benzocycloheptenes; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Florian Holsboer, MD, PHD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Breitenstein, MSc

CONTACT

0049 89 30622; barbara_breitenstein@mpipsykl.mpg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 12, 2014
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

DE (1)