Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000885291
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
25/05/2018
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a selective serotonin reuptake inhibitor (SSRI) on the brain's response to light
Scientific title
The effect of a single dose of citalopram compared to placebo on the brain's response to light in healthy adults
Secondary ID [1] 294501 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive disorders
 307275 0
Condition category
Condition code
Mental Health 306393 306393 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo an fMRI scan during which they are exposed to alternating ~30 second periods of light exposure, and ~30 second periods of dim light/darkness. A single dose of citalopram 30mg will be administered ~1 hour prior to the commencement of the scan. The total duration of the fMRI scan will be ~45 minutes. There will be a washout period of ~1 week between the active and control conditions.

fMRI sequence details are as follows: Gradient-echo echo-planar imaging (GRE-EPI) accelerated by parallel imaging using GRAPPA. TE = 30 ms, TR = 2.52 s, GRAPPA factor = 2, PE direction = anterior–posterior, FOV = 220 × 210 mm2, matrix size = 88 × 84, in-plane resolution = 2.5 × 2.5 mm2, slice thickness = 2.5 mm, inter-slice gap = 0.625 mm, and slice tilt = 40°. 45 slices acquired in ascending order for whole brain coverage including the lower brainstem.
Intervention code [1] 300797 0
Treatment: Drugs
Comparator / control treatment
Participants will undergo an fMRI scan during which they are exposed to alternating ~30 second periods of light exposure, and ~30 second periods of dim light/darkness. A single matched avicel powder filled placebo will be administered ~1 hour prior to the commencement of the scan. The total duration of the fMRI scan will be ~45 minutes. There will be a washout period of ~1 week between the active and control conditions.

fMRI sequence details are as follows: Gradient-echo echo-planar imaging (GRE-EPI) accelerated by parallel imaging using GRAPPA. TE = 30 ms, TR = 2.52 s, GRAPPA factor = 2, PE direction = anterior–posterior, FOV = 220 × 210 mm2, matrix size = 88 × 84, in-plane resolution = 2.5 × 2.5 mm2, slice thickness = 2.5 mm, inter-slice gap = 0.625 mm, and slice tilt = 40°. 45 slices acquired in ascending order for whole brain coverage including the lower brainstem.
Control group
Placebo

Outcomes
Primary outcome [1] 305404 0
Change in suprachiasmatic area activation to light measured with fMRI
Timepoint [1] 305404 0
Assessed at each fMRI scan (2 total, with ~one week between scans)
Secondary outcome [1] 345074 0
Change in neural activation related to arousal measured with fMRI
Timepoint [1] 345074 0
Assessed at each fMRI scan (2 total, with ~one week between scans)

Eligibility
Key inclusion criteria
Healthy Caucasian males and females
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any current diagnoses of psychiatric illness or use of psychiatric medication
- Current sleep disorders or erratic/unusual sleep patterns
- Recent or excessive illicit drug use
- Current use of any prescription medication
- Colourblindness
- Recent surgery involving a full anaesthetic
- Any night shift work within the past 3 months
- Any travel outside of the current time zone within the last 3 months
- BMI less than 18 or greater than 30
- Use of hormonal contraception
- Abnormal menstrual cycle (abnormally long, short or unpredictable)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will not be allocated a subject number (and therefore medication allocation) until they are deemed eligible for the study. If a participant withdraws, or is deemed otherwise ineligible after they have been allocated a subject number and randomisation order, only the study pharmacist will be aware of the randomisation order. As such, researchers making this decision will be blind to the order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation order will be generated by the study pharmacist, using simple randomisation software. The study pharmacist has no role in the recruitment, screening, or running of text subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Our sample size is based on a previous study where an n of 10 was adequate to observe light related change in suprachiasmatic area activity, which related to behavioural outcomes. Within-subjects, between conditions analyses will be used to compare outcome measures between placebo and citalopram trials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
20/06/2018
Date of last participant enrolment
Anticipated
16/11/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
24
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23312 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 299125 0
University
Name [1] 299125 0
Monash University
Country [1] 299125 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Clayton Campus
Wellington Road, Clayton
Victoria, Australia, 3800
Country
Australia
Secondary sponsor category [1] 298385 0
Individual
Name [1] 298385 0
Associate Professor Sean Cain
Address [1] 298385 0
Room 543 18 Innovation Walk
Clayton Campus
Wellington Road, Clayton
Victoria, Australia, 3800
Country [1] 298385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300059 0
Monash University Human Research Ethics Comittee
Ethics committee address [1] 300059 0
Clayton Campus
Wellington Road, Clayton
Victoria, Australia, 3800
Ethics committee country [1] 300059 0
Australia
Date submitted for ethics approval [1] 300059 0
09/01/2018
Approval date [1] 300059 0
29/01/2018
Ethics approval number [1] 300059 0
4940

Summary
Brief summary
This study will investigate the influence of a selective serotonin reuptake inhibitor (SSRI; citalopram) on the brains response to light stimuli, using fMRI scans. Participants will be healthy young men and women. Participants will complete two seperate fMRI scans, with ~1 week between scans. At each scan, participants will take either a single dose of citalopram 30mg, or placebo (in a randomised order) prior to undergoing a scan during which they are exposed to alternating periods of light and dark. We hypothesise an increase in the brain's response to light after citalopram administration, relative to placebo.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 82426 0
A/Prof Sean Cain
Address 82426 0
Room 543 18 Innovation Walk
Clayton Campus
Monash University
Clayton, Victoria, Australia, 3800
Country 82426 0
Australia
Phone 82426 0
+61 3 9905 1194
Fax 82426 0
Email 82426 0
[email protected]
Contact person for public queries
Name 82427 0
Sean Cain
Address 82427 0
Room 543 18 Innovation Walk
Clayton Campus
Monash University
Clayton, Victoria, Australia, 3800
Country 82427 0
Australia
Phone 82427 0
+61 3 9905 1194
Fax 82427 0
Email 82427 0
[email protected]
Contact person for scientific queries
Name 82428 0
Sean Cain
Address 82428 0
Room 543 18 Innovation Walk
Clayton Campus
Monash University
Clayton, Victoria, Australia, 3800
Country 82428 0
Australia
Phone 82428 0
+61 3 9905 1194
Fax 82428 0
Email 82428 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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