Brain Effects of Escitalopram and Citalopram Using fMRI

This study is currently recruiting participants.

Verified by Caritas St. Elizabeth's Medical Center of Boston, December 2009

First Received: January 19, 2009 Last Updated: December 28, 2009 History of Changes

Sponsor:	Caritas St. Elizabeth's Medical Center of Boston
Collaborator:	Forest Laboratories
Information provided by:	Caritas St. Elizabeth's Medical Center of Boston
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.

Condition	Intervention	Phase
Healthy	Drug: Escitalopram Drug: Citalopram Drug: Placebo	Phase IV

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

Resource links provided by NLM:

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

U.S. FDA Resources

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

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 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Active Comparator 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.
Citalopram: Active Comparator 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.
Placebo: Placebo Comparator 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

Contacts

Contact: Tara Lauriat, PhD

617-789-2404

depression@caritaschristi.org

Locations

United States, Massachusetts
Caritas St. Elizabeth's Medical Center	Recruiting
Boston, Massachusetts, United States, 02135
Contact: Tara Lauriat, PhD 617-789-2404 depression@caritaschristi.org
Principal Investigator: Michael E Henry, MD

Sponsors and Collaborators

Caritas St. Elizabeth's Medical Center of Boston

Forest Laboratories

Investigators

Principal Investigator:

Michael E Henry, MD

Caritas St. Elizabeth's Medical Center of Boston

More Information

No publications provided

Responsible Party:	Caritas St. Elizabeth's Medical Center ( Michael E. Henry, MD, Chairman, Department of Psychiatry, Caritas St. Elizabeth's Medical Center )
Study ID Numbers:	00397
Study First Received:	January 19, 2009
Last Updated:	December 28, 2009
ClinicalTrials.gov Identifier:	NCT00825825 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Caritas St. Elizabeth's Medical Center of Boston:

Citalopram
Escitalopram
Celexa
Lexapro

fMRI
antidepressant
healthy volunteers

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Citalopram

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010