Adjusting antidepressant dosage according to the patient's ABCB1 genotype

• Conditions: - Major Depression, single or recurrent, without psychotic features- Bipolar Disorders, currently depressed, without psychotic features; MedDRA version: 14.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: PTClassification code 10004940Term: Bipolar II disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-003190-29-DE
• Lead Sponsor: HolsboerMaschmeyer NeuroChemie (HMNC) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-16
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male and female patients
- Age between 18 and 80 years
- In-patients with a DSM-IV diagnosis of Major Depression
- - single episode or recurrent
- - moderate or severe intensity (indicated by a HAM-D score of = 14)
- - without psychotic features
- In-patients with a DSM-IV diagnosis of Bipolar Disorder
- - current episode depressed
- - moderate or severe intensity (indicated by a HAM-D score of = 14)
- - without psychotic features

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Acute suicidality (indicated by a HAM-D Item 3 score > 2)
- Acute substance abuse
- Severe somatic or neurological disorders
- Acute functional kidney disorders
- Untreated hypertonia
- In female patients: current pregnancy or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 21 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by ABCB1;Secondary Objective: To evaluate 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 ABCB1;Primary end point(s): Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D);Timepoint(s) of evaluation of this end point: After 21 days of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Self-reported improvement in the Beck Depression Inventory;Timepoint(s) of evaluation of this end point: After 21 days of treatment