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Adjusting antidepressant dosage according to the patient's ABCB1 genotype

Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication according to the the ABCB1 Gene - ABCB1 Clinical Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003190-29-DE
Enrollment
Unknown
Registered
2011-08-16
Start date
2012-01-30
Completion date
Unknown
Last updated
2012-05-29

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

Conditions

None listed

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: PAROXETINE CAS Number: 78246-49-8 Other descriptive name: PAROXETINE HYDROCHLORIDE Pharmaceutical Form: Tablet INN or Proposed INN: SERTRALINE HYDROCH

Sponsors

HolsboerMaschmeyer NeuroChemie (HMNC) GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Germany

Contacts

Public ContactABCB1 Study - Information

Max Planck Institute of Psychiatry

holsboer@mpipsykl.mpg.de004908930622221

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026