Effects of Intravenous (IV) Citalopram on Emotional Brain... | NCT01216449

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

NCT01216449

Sponsor

Rotman Research Institute at Baycrest

Status

Terminated

Last Update Posted

Mar 11, 2020Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Healthy Young and Elderly Volunteers

Interventions

Intravenous Citalopram
Normal Saline

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

loss of funding

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Mar 2016Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Name	Class
Centre for Addiction and Mental Health	OTHER
University of Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous Citalopram	Experimental		Drug: Intravenous Citalopram
Normal Saline	Placebo Comparator	250mL of 0.9% Sodium Chloride Solution	Drug: Normal Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Citalopram	Drug	Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes	Intravenous Citalopram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Visit 1, Visit 2

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce G Pollock, MD PhD FRCPC	Centre for Addiction and Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rotman Research Institute at Baycrest		Toronto	Ontario	M6A2E1	Canada

Type	Date	Date Unknown
Release	Oct 30, 2020
Reset	Nov 23, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 30, 2020			Nov 23, 2020

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

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Browse Branches

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