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Aripiprazole and Lexapro Drug Interaction Study

NCT ID: NCT00361790

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg

Intervention Type DRUG

Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.

Interventions

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Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg

Tablets, Oral, Escitalopram: 10 mg; Aripiprazole: 10, 15, 20 mg, once daily, 14 days.

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects, ages 18 to 45. (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy in minimized.
* Body Mass Index (BMI) of 18 to 33 kg/m2 inclusive.

Exclusion Criteria

* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
* Supine BP of 90/50 mm Hg or lower at screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Lenexa, Kansas, United States

Site Status

Countries

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United States

References

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Boulton DW, Balch AH, Royzman K, Patel CG, Berman RM, Mallikaarjun S, Reeves RA. The pharmacokinetics of standard antidepressants with aripiprazole as adjunctive therapy: studies in healthy subjects and in patients with major depressive disorder. J Psychopharmacol. 2010 Apr;24(4):537-46. doi: 10.1177/0269881108096522. Epub 2008 Oct 2.

Reference Type DERIVED
PMID: 18832427 (View on PubMed)

Other Identifiers

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CN138-463 ST

Identifier Type: -

Identifier Source: org_study_id