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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Perinatal treatment of depression
Scientific title
Maternal and infant outcomes following antenatal exposure to specific serotonin reuptake inhibitor (SSRI) and serotonin and noradrenaline reuptake inhibitor (SNRI )medications
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 4840 0
Condition category
Condition code
Mental Health 237183 237183 0 0

Study type
Description of intervention(s) / exposure
The intervention group will wean antidepressnt medication between 35 and 37 weeks of pregnancy, and then restart at one week post partum. The medications given will be any SSRI/SNRI medications given orally at dosage equivalents of up to 60mg of citalopram daily or 375mg of Venlafaxine daily. In many cases the participants will already be on the medications prior to being enrolled in the trial. In the group that weans they will continue their medication on a daily basis for as long as clinically indicated; usually at least twelve months post partum
Intervention code [1] 236619 0
Treatment: Drugs
Comparator / control treatment
Comparison groups - One group to wean and cease antidepressants at 35 weeks of pregnancy and one group to continue to term; group that weans will recommence antidepressant treatment at one week post partum and continue for as long as clinically indicated, usually at least telve months post partum.
Also control group of general population antenatal patients not receiving antidepressant therapy
Control group

Primary outcome [1] 238001 0
Maternal mental health as measured by depression rating scales Montgomery Asberg Depression Rating Scale(MADRS ) and Edinburgh Postnatal Depression Scale (EPND)
Timepoint [1] 238001 0
K28 ( 28 weeks pregnant), K38 (38 weeks pregnant), 3 days, 3 weeks, 3 months and 6 months post partum
Secondary outcome [1] 242135 0
Signs of foetal discontinuation as measured by Finnegan neonatal abstinence score and objective motion sensors
Timepoint [1] 242135 0
Day 1 to 4 post delivery

Key inclusion criteria
Pregnant, on SSRI/SNRI medications
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Comorbid substance abuse, use of benzodiazepines, and history of or current suicidality

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects enrolled by psychiatrist and clinical nurse consultant running trial; single blinded in that research assistants doing the outcome measures will be blind to treatment group. Subjects allocated using randomization generated by statistician external to trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Simple randomization using computer generated sequence
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4999 0
Name [1] 4999 0
Royal Brisbane Hospital
Address [1] 4999 0
Butterfield St
Herston Qld 4006
Country [1] 4999 0
Primary sponsor type
Royal Brisbane Hospital
Butterfield St
Herston Qld 4006
Secondary sponsor category [1] 4520 0
Name [1] 4520 0
Address [1] 4520 0
Country [1] 4520 0
Other collaborator category [1] 676 0
Name [1] 676 0
University of Queensland, School of Medicine, Department of Psychiatry
Address [1] 676 0
Butterfield St
Herston Qld 4006
Country [1] 676 0

Ethics approval
Ethics application status
Ethics committee name [1] 7101 0
Royal Brisbane Hospital
Ethics committee address [1] 7101 0
Butterfield St
Herston Qld 4006
Ethics committee country [1] 7101 0
Date submitted for ethics approval [1] 7101 0
Approval date [1] 7101 0
Ethics approval number [1] 7101 0

Brief summary
Purpose of the study is to examine mother and baby outcomes following exposure to antidepressant medication during pergnancy. Patients will be asked to either continue antidepressant medication up until and after delivery; or to wean medication at 35 weeks of pregnancy and recommence at one week post partum. The primary hypothesis is the women who continue their medication through delivery will have fewer depressive symptoms. The secondary hypothesis is that babies exposed to antidepressant medication to term will be more likely to have discontinuation symptoms such as jitteriness and irritability
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29635 0
Address 29635 0
Country 29635 0
Phone 29635 0
Fax 29635 0
Email 29635 0
Contact person for public queries
Name 12882 0
Dr Sally Matheson
Address 12882 0
Royal Brisbane Hospital
Butterfield St
Herston Qld 4006
Country 12882 0
Phone 12882 0
Fax 12882 0
Email 12882 0
Contact person for scientific queries
Name 3810 0
Dr Sally Matheson
Address 3810 0
Royal Brisbane Hospital
Butterfield St
Herston Qld 406
Country 3810 0
Phone 3810 0
+617 36362505
Fax 3810 0
Email 3810 0

No information has been provided regarding IPD availability
Summary results
No Results