Clinical trial NCT00825825: Brain Effects of Escitalopram and Citalopram Using fMRI
Official title: A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antidepressant Activity in Healthy Volunteers
Keywords: Citalopram
Escitalopram
Celexa
Lexapro
fMRI
antidepressant
healthy volunteers
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-01-21
Enrollment: 27
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.
timeFrame: two weeks
Secondary outcomes:
measure: Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.
timeFrame: 2 weeks
measure: Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
timeFrame: 2 weeks
measure: Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
timeFrame: 2 weeks
measure: Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
timeFrame: 2 weeks
measure: Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
timeFrame: 2 weeks
measure: Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center
name: Michael E Henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.neuroimage.2009.10.013. Epub 2009 Oct 13.