Antidepressant Activity in Healthy VolunteersPhase 4NCT00825825

Brain Effects of Escitalopram and Citalopram Using fMRI

A Phase 4 study testing Escitalopram and Citalopram in people with Antidepressant Activity in Healthy Volunteers, run by Michael Henry, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Antidepressant Activity in Healthy Volunteers
What is being tested?: Escitalopram and Citalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: May 2007to Apr 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135

Other trials in United States

About this study

Official title: A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI

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
Being tested: Escitalopram, Citalopram, Placebo
Keywords: Citalopram, Escitalopram, Celexa, Lexapro, fMRI, antidepressant, healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Also called Lexapro
One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.
CitalopramDrug
Also called Celexa
One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.
PlaceboDrug
Two weeks of placebo taken orally.

Study groups in NCT00825825
Study group	Role	What they receive
Escitalopram	Active comparator	One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers. Receives: Drug: Escitalopram
Citalopram	Active comparator	One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers. Receives: Drug: Citalopram
Placebo	Placebo comparator	Two weeks of placebo in healthy volunteers. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 2 weeks
Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
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.
Measured: 2 weeks
Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
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.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Apr 2011

First posted21 Jan 2009 (estimated)
Study startMay 2007
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Antidepressant Activity in Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00825825
Sponsor's protocol ID: 00397
Status last verified: Jun 2015
First submitted: 19 Jan 2009
Last updated: 14 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 19833214

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Fluoxetine and Understanding Social Experiences
Depression in Adolescence, Antidepressant Activity in Healthy Volunteers

All Antidepressant Activity in Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI
ClinicalTrials.gov ID: NCT00825825
Acronym / sponsor ID: 00397
Conditions: Antidepressant Activity in Healthy Volunteers
Keywords: Citalopram, Escitalopram, Celexa, Lexapro, fMRI, antidepressant, healthy volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Michael Henry, MDUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: May 2007
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 21 Jan 2009 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Escitalopram	Active comparator	Drug: EscitalopramOne week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers.
Citalopram	Active comparator	Drug: CitalopramOne week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers.
Placebo	Placebo comparator	Drug: PlaceboTwo weeks of placebo in healthy volunteers.

Who may qualify

Ages: 21 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EscitalopramAlso: LexaproOne week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.	Drug	Escitalopram
CitalopramAlso: CelexaOne week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.	Drug	Citalopram
PlaceboTwo weeks of placebo taken orally.	Drug	Placebo

Primary outcome

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.

6 secondary outcomes

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
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
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
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
Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
Time frame: 2 weeks
Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
Time frame: 2 weeks

Results and safety

Results posted to the registry on 3 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Escitalopram First / Citalopram Second / Placebo Third	6	3
Escitalopram First / Placebo Second / Citalopram Third	4	4
Citalopram First / Escitalopram Second / Placebo Third	3	2
Citalopram First / Placebo Second / Escitalopram Third	5	5
Placebo First / Escitalopram Second / Citalopram Third	4	4
Placebo First / Citalopram Second / Escitalopram Third	5	3

Primary outcome: 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. Number. Unit: voxels

Measure	All Participants With Complete Usable Data n = 11
Value	478

All Participants With Complete Usable Data: p = 0.000704, Mixed Models Analysis

Population analysed: Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected beginning with the date of the screening visit and ending with the final study visit. The average time period was approximately 4 months but varied due to differences in the length of the screening period.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Escitalopram	0 of 22 (0%)	1 of 22 (4.5%)	Not reported
Citalopram	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Placebo	0 of 21 (0%)	1 of 21 (4.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19833214Windischberger 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.

Related trials for Antidepressant Activity in Healthy Volunteers

Not yet recruiting
Fluoxetine and Understanding Social Experiences
Depression in Adolescence, Antidepressant Activity in Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael E Henry, MD principal investigator

Steward St. Elizabeth's Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram and Citalopram in people with Antidepressant Activity in Healthy Volunteers, run by Michael Henry, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00825825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (3 listed)

Key exclusion criteria (8 listed)

Interventions

Primary outcome

Results and safety

Participant flow

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

Adverse events

Research links

Related trials for Antidepressant Activity in Healthy Volunteers

Fluoxetine and Understanding Social Experiences

Referral and contact

Questions about this trial

Participant flow

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

Adverse events