Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Effects of Escitalopram and Citalopram Using fMRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00825825
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : September 3, 2012
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Michael Henry, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Tracking Information
First Submitted Date  ICMJE January 19, 2009
First Posted Date  ICMJE January 21, 2009
Results First Submitted Date  ICMJE June 11, 2012
Results First Posted Date  ICMJE September 3, 2012
Last Update Posted Date July 14, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation. [ Time Frame: two weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
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 ]
Change History Complete list of historical versions of study NCT00825825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
  • Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked 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 right insular cortex.
  • 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. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.
  • 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. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.
  • 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. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.
  • Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.
  • Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus. [ Time Frame: 2 weeks ]
    Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. 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 primary visual cortex.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
  • Change in Quick Inventory of Depressive Symptomatology (QIDS) score. [ Time Frame: 2 weeks ]
  • Change in Young Mania Rating Scale (YMRS) score. [ Time Frame: 2 weeks ]
  • Change in Discontinuation Emergent Signs and Symptoms (DESS) score. [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Effects of Escitalopram and Citalopram Using fMRI
Official Title  ICMJE A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Antidepressant Activity in Healthy Volunteers
Intervention  ICMJE
  • Drug: Escitalopram
    One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.
    Other Name: Lexapro
  • Drug: Citalopram
    One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.
    Other Name: Celexa
  • Drug: Placebo
    Two weeks of placebo taken orally.
Study Arms  ICMJE
  • Active Comparator: Escitalopram
    One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers.
    Intervention: Drug: Escitalopram
  • Active Comparator: Citalopram
    One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers.
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo
    Two weeks of placebo in healthy volunteers.
    Intervention: Drug: Placebo
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. doi: 10.1016/j.neuroimage.2009.10.013. Epub 2009 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2012)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2009)
15
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00825825
Other Study ID Numbers  ICMJE 00397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Henry, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.
Study Sponsor  ICMJE Michael Henry, MD
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Michael E Henry, MD Steward St. Elizabeth's Medical Center
PRS Account Steward St. Elizabeth's Medical Center of Boston, Inc.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP