Brain Effects of Escitalopram and Citalopram Using fMRI

NCT ID: NCT00825825

Last Updated: 2015-07-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antidepressant Activity in Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Escitalopram

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

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

Citalopram

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

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

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

Placebo

Two weeks of placebo in healthy volunteers.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two weeks of placebo taken orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Escitalopram

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

Intervention Type DRUG

Citalopram

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

Intervention Type DRUG

Placebo

Two weeks of placebo taken orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lexapro Celexa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Michael Henry, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Henry, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael E Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19833214 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00397

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pattern Separation in Major Depressive Disorder
NCT07139834 NOT_YET_RECRUITING PHASE1
Somatosensory Processing in Depression
NCT00386893 WITHDRAWN PHASE4
Escitalopram Effects on CSF Amyloid Beta
NCT02161458 COMPLETED PHASE4
Neurotrophic Factors and Depression
NCT00812994 COMPLETED PHASE4