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The National Register of Antipsychotic Medication in Pregnancy (NRAMP) (NRAMP)

This study is currently recruiting participants.
Verified January 2017 by Jayashri Kulkarni, Professor, The Alfred
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686946
First Posted: May 30, 2008
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Janssen-Cilag Ltd.
AstraZeneca
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
  Purpose

The National Register of Antipsychotic Medication in Pregnancy (NRAMP)is an observational, nationwide study involving women of child-bearing age who take antipsychotic medication during pregnancy. It follows the pathway of mother and baby during pregnancy and for the first 12 months of the baby's life, in order to develop evidence-based guidelines for the best use and effect of antipsychotic medication during pregnancy, thereby informing clinical treating teams with regard to the management of their patients in this vulnerable population group.

The investigators hypothesize that the provision of such evidence-based guidelines will improve the management and outcomes for mother and baby during pregnancy, birth and the postnatal phase, providing a positive impact on maternal and child health and wellbeing for present and future generations.


Condition
Pregnancy Mental Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The National Register of Antipsychotic Medication in Pregnancy (NRAMP)

Resource links provided by NLM:


Further study details as provided by Jayashri Kulkarni, Professor, The Alfred:

Primary Outcome Measures:
  • Participant interviews [ Time Frame: Antenatal - once per trimester; Postnatal - quarterly for 12 months ]
    Interviews to gather demographic, social, medical, psychiatric, medication and obstetric history


Secondary Outcome Measures:
  • Psychopathology measures for the mother [ Time Frame: Antenatal and up to 12 months postnatally ]
    PANSS (Positive and Negative Syndrome Scale) Questionnaire EPDS (Edinburgh Postnatal Depression Scale)Questionnaire

  • Developmental Milestone measures for the baby [ Time Frame: Birth to 12 months of age ]
    ASQ-3 (Ages and Stages Questionnaire, Third Edition)


Estimated Enrollment: 500
Study Start Date: January 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
NRAMP
Participants take their antipsychotic medication as prescribed by their clinical treating teams.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women from across Australia who are taking, or have taken, antipsychotic medication during pregnancy
Criteria

Inclusion Criteria:

  • Women who take antipsychotic medication during pregnancy
  • Women who are pregnant or have had a baby in the last 12 months
  • Women who are living in Australia
  • Women who are able to provide informed consent

Exclusion Criteria:

  • Women who do not take antipsychotic medication during pregnancy
  • Women who are not pregnant, or have not had a baby in the last 12 months
  • Women who are unable to provide informed consent
  Contacts and Locations
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): NCT00686946


Contacts
Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP 61-3-9076-6564 jayashri.kulkarni@med.monash.edu.au
Contact: Ms Heather Gilbert, RN Div 1 61-3-9076-6591 heather.gilbert@monash.edu

Locations
Australia, Victoria
Monash Alfred Pyschiatry Research Centre, Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP    61-3-9076-6564    jayashri.kulkarni@med.monash.edu.au   
Contact: Ms Heather Gilbert, RN Div 1    61-3-9076-6591    heather.gilbert@monash.edu   
Principal Investigator: Prof Jayashri Kulkarni, MBBS,FRANZCP         
Sponsors and Collaborators
The Alfred
Janssen-Cilag Ltd.
AstraZeneca
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Prof Jayashri Kulkarni, MBBS,FRANZCP Monash Alfred Psychiatry Research Centre (MAPrc)
  More Information

Responsible Party: Jayashri Kulkarni, Professor, Chief Investigator, The Alfred
ClinicalTrials.gov Identifier: NCT00686946     History of Changes
Other Study ID Numbers: 114/04
First Submitted: May 28, 2008
First Posted: May 30, 2008
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared, for example, in Case Studies, where personal identification is not compromised, which also allows for an aggregate view of data.

Keywords provided by Jayashri Kulkarni, Professor, The Alfred:
Severe mental illness
Antipsychotic medications
Pregnancy
Evidence-based guidelines
Maternal and infant health and wellbeing

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs