Brain Effects of Escitalopram and Citalopram Using fMRI - Full Text View

Sponsor:	Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborator:	Forest Laboratories
Information provided by:	Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:	NCT00825825

Purpose

Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating mood. Escitalopram consists of S-citalopram while citalopram contains both S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may block the effects of S-citalopram. The hypothesis being tested is that because of the antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood circuit than racemic citalopram when equal doses of S-citalopram are administered. The study design consists of a two week medication period followed by blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.

Condition	Intervention	Phase
Antidepressant Activity in Healthy Volunteers	Drug: Escitalopram Drug: Citalopram Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:

Change in BOLD fMRI signal in regions of interest including prefrontal cortex, orbitofrontal cortex, caudate, anterior cingulate gyrus, amygdala, and hippocampus. [ Time Frame: Two weeks (each medication period) ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Escitalopram One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers.	Drug: Escitalopram One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily. Other Name: Lexapro
Active Comparator: Citalopram One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers.	Drug: Citalopram One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily. Other Name: Celexa
Placebo Comparator: Placebo Two weeks of placebo in healthy volunteers.	Drug: Placebo Two weeks of placebo taken orally.

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male aged 21 to 50 years.
Capable of providing informed consent.
Has an established residence and phone.

Exclusion Criteria:

Meets DSM-IV criteria for an Axis I or II disorder.
History of substance dependence or abuse within the past month.
Use of NSAID's, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator would alter vascular responsivity.
Regular use of sedative hypnotic or narcotic medication, or other medication that might affect the individual's perception of visual stimuli.
History of cataracts or significant visual impairment.
A medical condition, which in the opinion of the investigator is likely to affect the individual's perception of the visual stimuli or vascular response.
Participation in a research protocol that included administration of medication within the past 3 months.
Cigarette smoking.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825825

Locations

United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135

Sponsors and Collaborators

Steward St. Elizabeth's Medical Center of Boston, Inc.

Forest Laboratories

Investigators

Principal Investigator:

Michael E Henry, MD

Steward St. Elizabeth's Medical Center of Boston, Inc.

More Information

Publications:

Windischberger C, Lanzenberger R, Holik A, Spindelegger C, Stein P, Moser U, Gerstl F, Fink M, Moser E, Kasper S. Area-specific modulation of neural activation comparing escitalopram and citalopram revealed by pharmaco-fMRI: a randomized cross-over study. Neuroimage. 2010 Jan 15;49(2):1161-70. Epub 2009 Oct 13.

Responsible Party:	Michael E. Henry, MD, Chairman, Department of Psychiatry, Caritas St. Elizabeth's Medical Center, Caritas St. Elizabeth's Medical Center
ClinicalTrials.gov Identifier:	NCT00825825 History of Changes
Other Study ID Numbers:	00397
Study First Received:	January 19, 2009
Last Updated:	April 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Citalopram
Escitalopram
Celexa
Lexapro

fMRI
antidepressant
healthy volunteers

Additional relevant MeSH terms:

Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012