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Trial record 76 of 135 for:    AMITRIPTYLINE

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

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ClinicalTrials.gov Identifier: NCT02237937
Recruitment Status : Unknown
Verified September 2014 by HolsboerMaschmeyer NeuroChemie GmbH.
Recruitment status was:  Recruiting
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Collaborator:
Max-Planck-Institute of Psychiatry
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Major Depression Drug: Paroxetine Drug: Sertraline Drug: Citalopram Drug: Venlafaxine Drug: Amitriptyline Drug: Escitalopram Drug: Amitriptylinoxide Drug: Nortriptyline Drug: Trimipramine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
Study Start Date : September 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal dosage

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
Experimental: High dosage

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



Primary Outcome Measures :
  1. 25% improvement in the HAM-D [ Time Frame: 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 :
  1. side effects [ Time Frame: after 28 days of treatment ]
    UKU side effect scale, AMDP side effect scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237937


Contacts
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Contact: Barbara Breitenstein, MSc 0049 89 30622 ext 244 barbara_breitenstein@mpipsykl.mpg.de

Locations
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Germany
Max Planck Institute of Psychiatry Recruiting
Munich, Bavaria, Germany, 80804
Principal Investigator: Barbara Breitenstein, MSc         
Sponsors and Collaborators
HolsboerMaschmeyer NeuroChemie GmbH
Max-Planck-Institute of Psychiatry
Investigators
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Principal Investigator: Florian Holsboer, MD, PHD Max-Planck-Institute of Psychiatry

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Responsible Party: HolsboerMaschmeyer NeuroChemie GmbH
ClinicalTrials.gov Identifier: NCT02237937     History of Changes
Other Study ID Numbers: 2011-003190-29
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by HolsboerMaschmeyer NeuroChemie GmbH:
Depression, Affective Disorder
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Depression
Behavioral Symptoms
Dexetimide
Antidepressive Agents
Citalopram
Sertraline
Paroxetine
Venlafaxine Hydrochloride
Nortriptyline
Trimipramine
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Cytochrome P-450 CYP2D6 Inhibitors