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

NCT01216449 | Terminated DMC

• 1 other identifier: 08-39
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Young and Elderly Volunteers

Keywords

Citalopram; Functional Magnetic Resonance Imaging; fMRI; Pharmacokinetics; Pharmacodynamics; Amygdala; Elderly

Outcome Measures

Primary Outcomes (1)

• BOLD fMRI Response

  Changes in affect-related neuronal activation as measured by blood oxygenation level-dependent (BOLD) fMRI response to IV citalopram are the primary outcome measures. Imaging data will be compared between IV citalopram and placebo administration and young and old adults.

  Visit 1, Visit 2

Secondary Outcomes (1)

• Genetics and Cognitive/Emotional Change

  Visit 1, Visit 2

Study Arms (2)

Intravenous Citalopram

EXPERIMENTAL

Drug: Intravenous Citalopram

Normal Saline

PLACEBO COMPARATOR

250mL of 0.9% Sodium Chloride Solution

Drug: Normal Saline

Interventions

Intravenous Citalopram DRUG

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

Intravenous Citalopram

Normal Saline DRUG

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

Normal Saline

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: lead
• Centre for Addiction and Mental Health: collaborator
• University of Toronto: collaborator

Study Sites (1)

Rotman Research Institute at Baycrest

Toronto, Ontario, M6A2E1, Canada

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bruce G Pollock, MD PhD FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP Research

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: April 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2016
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

CA (1)