Effects of Intravenous (IV) Citalopram on Emotional Brain Activity in Healthy Young and Elderly Adults

NCT ID: NCT01216449

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-03-31

Brief Summary

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Antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs) are most commonly prescribed to treat depression and anxiety. How antidepressants work on the brain to alter mood and behaviour is not well understood. This study will use a brain scanning technique (functional magnetic resonance imaging) to examine how aging impacts brain activation during emotional tasks after the administration of intravenous (IV) citalopram (this is the only SSRI available in this form, and is well tolerated and safe in young and old adults). The investigators will further determine what role genetic differences play in this relationship. The investigators expect to see an increase in brain signal as the concentration of IV citalopram increases. However, the investigators propose that the brain signal in older adults will not be as strong as in younger adults. Furthermore, the investigators expect that participants genetically predisposed to have fewer serotonin transporters (the site of action of SSRIs) will show greater decreases in brain activation with citalopram.

Detailed Description

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Conditions

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Healthy Young and Elderly Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravenous Citalopram

Group Type EXPERIMENTAL

Intravenous Citalopram

Intervention Type DRUG

Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes

Normal Saline

250mL of 0.9% Sodium Chloride Solution

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Single dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes

Interventions

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Intravenous Citalopram

Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes

Intervention Type DRUG

Normal Saline

Single dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male aged 60 or older (elderly group)
* Male aged 20-40 (younger adult group)
* English speaking
* Right-handed
* Non-smoker
* Score of 27 or greater on the Mini Mental State Exam

Exclusion Criteria

* Unstable medical, cardiac, or neurological illness (including stroke, brain tumour, epilepsy, significant head injury, Alzheimer's, Parkinson's or Huntington's disease)
* Laboratory results indicating unanticipated illness or intolerability of blood drawing procedures or of study drug
* Current or lifetime Axis-I psychiatric diagnosis on the DSM-IV/SCID (i.e., Module A: Mood, Module F: Anxiety, Module B \& C: Psychosis)
* History of drug or alcohol abuse within one year, or lifetime history of alcohol or drug dependence (i.e., SCID Module E: Substance Abuse, or clinically significant urine toxicology screen)
* History of non-tolerance to SSRI therapy; including history of SSRI-related syndrome of inappropriate antidiuretic hormone secretion (SIADH) or sinus bradycardia on ECG (less than 50 beats per minute)
* Contraindication to MRI (as per MRI Contraindication Screening Form)
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Rotman Research Institute at Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Bruce Pollock

VP Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce G Pollock, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Rotman Research Institute at Baycrest

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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08-39

Identifier Type: -

Identifier Source: org_study_id

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