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Trial record 41 of 152 for:    HTT

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

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ClinicalTrials.gov Identifier: NCT01216449
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Centre for Addiction and Mental Health
University of Toronto
Information provided by (Responsible Party):
Bruce Pollock, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Healthy Young and Elderly Volunteers Drug: Intravenous Citalopram Drug: Normal Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Pharmacodynamics of Intravenous Citalopram in the Elderly: a Functional Magnetic Resonance Imaging Analysis
Study Start Date : April 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous Citalopram Drug: Intravenous Citalopram
Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes

Placebo Comparator: Normal Saline
250mL of 0.9% Sodium Chloride Solution
Drug: Normal Saline
Single dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes




Primary Outcome Measures :
  1. BOLD fMRI Response [ Time Frame: Visit 1, Visit 2 ]
    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.


Secondary Outcome Measures :
  1. Genetics and Cognitive/Emotional Change [ Time Frame: Visit 1, Visit 2 ]
    Secondary measures include analysis of the relationship between 5HTT polymorphism and neuronal activation, and changes in cognitive and emotional assessments between IV citalopram and placebo.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216449


Locations
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Canada, Ontario
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada, M6A2E1
Sponsors and Collaborators
Rotman Research Institute at Baycrest
Centre for Addiction and Mental Health
University of Toronto
Investigators
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Principal Investigator: Bruce G Pollock, MD PhD FRCPC Centre for Addiction and Mental Health

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Responsible Party: Bruce Pollock, VP Research, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01216449     History of Changes
Other Study ID Numbers: 08-39
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Keywords provided by Bruce Pollock, Centre for Addiction and Mental Health:
Citalopram
Functional Magnetic Resonance Imaging
fMRI
Pharmacokinetics
Pharmacodynamics
Amygdala
Elderly

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents