Phase 4
N=27
Brain Effects of Escitalopram and Citalopram Using fMRI
Antidepressant Activity in Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00825825 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation. — 478 voxels — p=0.000704
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug); Citalopram (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Michael Henry, MD
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation. |
478 | 0.000704 sig |
| SECONDARY Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation. |
735 | 0.0000162 sig |
| SECONDARY 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. |
253 | 0.0279 sig |
| SECONDARY 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. |
253 | 0.0279 sig |
| SECONDARY 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. |
396 | 0.00124 sig |
| SECONDARY Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus. |
619 | 0.0000633 sig |
| SECONDARY Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus. |
289 | 0.0241 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00825825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.