Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: Moxifloxacin; Drug: Escitalopram; Drug: Quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01871701

CNSQT

Details and patient eligibility

About

To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.

Full description

Randomized, Open-label, Placebo-controlled, 4-way crossover study

Enrollment: 40 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects aged 20 - 40 years.
2. A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion criteria

1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
2. Subject judged not eligible for study participation by investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups, including a placebo group

Quetiapine

Experimental group

Description:

Quetiapine 100 mg (Seroquel, Tablet)

Treatment:

Drug: Quetiapine

Moxifloxacin

Experimental group

Description:

Moxifloxacin 400 mg (Avelox, Tablet)

Treatment:

Drug: Moxifloxacin

Escitalopram

Experimental group

Description:

Escitalopram 20 mg (Lexapro, Tablet)

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

Water intake

Treatment:

Other: Placebo