Effects of Intravenous (IV) Citalopram on Emotional Brain Activity in Healthy Young and Elderly Adults
Information source: Rotman Research Institute at Baycrest
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Young and Elderly Volunteers
Intervention: Intravenous Citalopram (Drug); Normal Saline (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Rotman Research Institute at Baycrest Official(s) and/or principal investigator(s): Bruce G Pollock, MD PhD FRCPC, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
Overall contact: Christina E Pataky Forsyth, HBSc, Phone: 416-655-4666, Email: cpataky@research.baycrest.org
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.
Clinical Details
Official title: Pharmacodynamics of Intravenous Citalopram in the Elderly: a Functional Magnetic Resonance Imaging Analysis
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: BOLD fMRI Response
Secondary outcome: Genetics and Cognitive/Emotional Change
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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)
Locations and Contacts
Christina E Pataky Forsyth, HBSc, Phone: 416-655-4666, Email: cpataky@research.baycrest.org
Rotman Research Institute at Baycrest, Toronto, Ontario M6A2E1, Canada; Recruiting Christina E Pataky Forsyth, HBSc, Phone: 416-655-4666 Bruce G Pollock, MD PhD FRCPC, Principal Investigator Christina E Pataky Forsyth, HBSc, Sub-Investigator Tiffany W Chow, MD, MSc, Sub-Investigator Aristotle Voineskos, MD PhD FRCPC, Sub-Investigator Howard Aizenstein, MD, PhD, Sub-Investigator Robert Bies, PharmD, PhD, Sub-Investigator Cheryl Grady, PhD, Sub-Investigator James Kennedy, MD, Sub-Investigator A. Randy McIntosh, PhD, Sub-Investigator Laura Wagner, PhD, RN, Sub-Investigator
Additional Information
Starting date: April 2009
Last updated: November 4, 2014
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