Brain Effects of Escitalopram and Citalopram Using fMRI

NCT00825825 | Completed Phase 4 Results

• 1 other identifier: 00397
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Antidepressant Activity in Healthy Volunteers

Keywords

Citalopram; Escitalopram; Celexa; Lexapro; fMRI; antidepressant; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.

  Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.

  two weeks

Secondary Outcomes (6)

• Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• 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.

  2 weeks

• Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.

  2 weeks

Study Arms (3)

Escitalopram

ACTIVE COMPARATOR

One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers.

Drug: Escitalopram

Citalopram

ACTIVE COMPARATOR

One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers.

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Two weeks of placebo in healthy volunteers.

Drug: Placebo

Interventions

Escitalopram DRUG

One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.

Also known as: Lexapro

Escitalopram

Citalopram DRUG

One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.

Also known as: Celexa

Citalopram

Placebo DRUG

Two weeks of placebo taken orally.

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Henry, MD: lead
• Forest Laboratories: collaborator

Study Sites (1)

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Related Publications (1)

• 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.

  PMID: 19833214 BACKGROUND

MeSH Terms

Interventions

Escitalopram; Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Data from several subjects had to be excluded due to one or more fMRI scans with poor data quality (usually high motion) or scheduling problems that prevented a scan from occuring during the specified time window.

Results Point of Contact

• Title: Tara Lauriat, Ph.D.
• Organization: Steward St. Elizabeth's Medical Center

tara.lauriat@steward.org

617-789-2404

Study Officials

• Michael E Henry, MD

  Steward St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: May 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 14, 2015
• Results First Posted: September 3, 2012

Record last verified: 2015-06

Locations

US (1)