Aripiprazole and Lexapro Drug Interaction Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: 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	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Citalopram hydrobromide Citalopram Aripiprazole Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Multiple dose PK parameters for Lexapro when administered alone and coadministered with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured

Secondary Outcome Measures:

Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs

Estimated Enrollment:	25
Study Start Date:	August 2006
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: 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. Other Name: Abilify

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361790

Locations

United States, Kansas
Local Institution
Lenexa, Kansas, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Oct 2.

ClinicalTrials.gov Identifier:	NCT00361790 History of Changes
Other Study ID Numbers:	CN138-463 ST
Study First Received:	August 7, 2006
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Healthy Subjects

Additional relevant MeSH terms:

Dexetimide
Citalopram
Aripiprazole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013