Healthy Young and Elderly VolunteersNCT01216449
Effects of Intravenous (IV) Citalopram on Emotional Brain Activity in Healthy Young and Elderly Adults
A study testing Intravenous Citalopram and Normal Saline in people with Healthy Young and Elderly Volunteers, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young and Elderly Volunteers
- What is being tested?
- Intravenous Citalopram and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamics of Intravenous Citalopram in the Elderly: a Functional Magnetic Resonance Imaging Analysis
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
- Being tested
- Intravenous Citalopram, Normal Saline
- Keywords
- Citalopram, Functional Magnetic Resonance Imaging, fMRI, Pharmacokinetics, Pharmacodynamics, Amygdala, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous CitalopramDrug
Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes
Normal SalineDrug
Single dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Citalopram | Experimental | Not described Receives: Drug: Intravenous Citalopram |
| Normal Saline | Placebo comparator | 250mL of 0.9% Sodium Chloride Solution Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1, Visit 2
Secondary outcomes (1)
Genetics and Cognitive/Emotional Change
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.
Measured: Visit 1, Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionMar 2016
Why it stopped: loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young and Elderly VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, University of Toronto
- Responsible party
- Principal investigator, Bruce Pollock, Centre for Addiction and Mental Health
- Investigators
- Bruce G Pollock, MD PhD FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216449
- Sponsor's protocol ID
- 08-39
- Status last verified
- Mar 2020
- First submitted
- 6 Oct 2010
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics of Intravenous Citalopram in the Elderly: a Functional Magnetic Resonance Imaging Analysis
- ClinicalTrials.gov ID
- NCT01216449
- Acronym / sponsor ID
- 08-39
- Conditions
- Healthy Young and Elderly Volunteers
- Keywords
- Citalopram, Functional Magnetic Resonance Imaging, fMRI, Pharmacokinetics, Pharmacodynamics, Amygdala, Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: loss of funding
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, University of Toronto
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Citalopram | Experimental | Drug: Intravenous Citalopram |
| Normal Saline | Placebo comparator | Drug: Normal Saline250mL of 0.9% Sodium Chloride Solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male aged 60 or older (elderly group)
- Male aged 20-40 (younger adult group)
- English speaking
- Right-handed
- Non-smoker
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous CitalopramSingle dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes | Drug | Intravenous Citalopram |
| Normal SalineSingle dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes | Drug | Normal Saline |
Primary outcome
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.
1 secondary outcome
Genetics and Cognitive/Emotional Change
Time frame: Visit 1, Visit 2
Results and safety
The study was stopped early (reason given: loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce G Pollock, MD PhD FRCPC principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Citalopram and Normal Saline in people with Healthy Young and Elderly Volunteers, run by Rotman Research Institute at Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: loss of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD fMRI Response (time frame: Visit 1, Visit 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.