Bipolar DisorderNCT03774641
A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
An observational study of Bipolar Disorder and Major Depressive Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder, Schizo Affective Disorder
- What is being tested?
- Lamictal
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 16 Apr 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who are currently taking Lamotrigine for Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder, or another psychiatric illness, and plan to continue throughout pregnancy.
Who may be able to join
- pregnant, prior or 20 weeks
- currently taking Lamotrigine and plan to continue throughout pregnancy
- history of Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder or other psychiatric illness, currently stable
- may be taking other psychiatric medications
Who cannot join
- suicidal/clinically unstable
- alcohol, marijuana, or other drug dependence in last 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women
Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.
Read the detailed description
Studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. However, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. One likely explanation for the high relapse rate of Bipolar Disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. Pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. Therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. Therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. Most pregnant psychiatric patients are therefore managed based on symptom recurrence. In contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. The investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with Bipolar Disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. In the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.
- Being tested
- Lamictal
- Keywords
- Lamotrigine, Bipolar Disorder, Major Depressive Disorder, Schizo Affective Disorder
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamictalDrug
Also called Lamotrigine
Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained
| Study group | Role | What they receive |
|---|---|---|
| Taking Lamotrigine | Lamotrigine (Lamictal), dosage will be based on a reference concentration of blood-serum levels Receives: Drug: Lamictal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mood as assessed by The Edinburgh Postnatal Rating Scale
Self-reported experience of depressive symptoms over the past 7 days, each item is scored 0-3 (0=not experiencing the symptom, 3=experiencing the symptom most of the time) yielding a total between 0 and 30. A score of 0-9 indicates little to no depressive symptoms and a score from 10-30 indicates significant depressive symptoms.
Measured: Monthly, after enrollment, up to 10 months
Change in Mood as assessed by The Young Mania Rating Scale
Clinical interview that measures manic symptoms in the past 2 weeks, each item is scored 0-4 (0=absent, 4=fully present) yielding a total between 0 and 44. Any score above 0 indicates a possible manic episode.
Measured: Monthly, after enrollment, up to 10 months
Side Effect as assessed by the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale
Clinical interview that measures current, or in the past 72 hours, side effects of medication, each item is scored 0-3 (0=not or doubtfully present, 3=severe), yielding a total between 0 and 168. Any score above 0 indicates a possible causal relationship between medication and side effects.
Measured: Monthly, after enrollment, up to 10 months
Side Effect as assessed by the Frequency, Intensity, and Burden of Side Effects Rating Scale
Self-reported frequency, intensity, and burden of side effects in the past week, each item is scored 0-6 (0=no side effects/impairment, 6=present all the time/intolerable/unable to function) yielding a total between 0 and 18. For each item, a score of 0-2 indicates treatment should continue, a score of 3-4 indicates the side effect should be addressed, and a score of 5-6 indicates a change in treatment is needed.
Measured: Monthly, after enrollment, up to 10 months
Change in Infant Habituation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's ability to shut down response to a stimulus, the item is scored 1-9, a low score indicates no decrement in response over 10 stimuli and a high score indicates a shut down of response after 1-2 stimuli
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Attention as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's response to a stimulus, the item is scored 1-9, a low score indicates no response and a high score indicates alerting to stimulus
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Self-Regulation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's ability to self-regulate, the item is scored 1-9, a low score indicates the infant makes no attempt to quiet self and a high score indicates the infant consistently quiets self for sustained periods
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Arousal as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's arousal, the item is scored 1-9, a low score indicates a low level of arousal to all stimuli and a high score indicates the infant achieves insulated crying
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Tonicity as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's body tone, the item is scored 1-9, a low score indicates the infant is flaccid and a high score indicates the infant is hypertonic
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Reflexes as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's reflexes, the item is scored 1-5, a low score indicates no response and a high score indicates a strong response
Measured: At 1, 2, 4, and 6 weeks postpartum
Change in Infant Quality of Movement as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Neurobehavioral assessment measuring infant's power and flexibility, the item is scored 1-5, a low score indicates no resistance/movement and a high score indicates strong resistance/movement
Measured: At 1, 2, 4, and 6 weeks postpartum
Gestational Age at Birth in Weeks assessed by Review of the Infant Delivery Chart
Measured: At 2 weeks postpartum visit, up to 15 minutes
Birth Length in Inches assessed by Review of the Infant Delivery Chart
Measured: At 2 weeks postpartum visit, up to 15 minutes
Birth Weight in pounds assessed by Review of the Infant Delivery Chart
Measured: At 2 weeks postpartum visit, up to 15 minutes
APGAR Score at 1 Minute assessed by Review of the Infant Delivery Chart
Measured: At 2 weeks postpartum visit, up to 15 minutes
APGAR Score at 5 Minutes assessed by Review of the Infant Delivery Chart
Measured: At 2 weeks postpartum visit, up to 15 minutes
Assessment of Neonatal Intensive Care Unit Admission by Review of the Infant Delivery Chart
By reviewing the infant delivery chart, the outcome will be "yes" if the infant was admitted to the Neonatal Intensive Care Unit and "no" if the infant was not admitted
Measured: At 2 weeks postpartum visit, up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start3 Dec 2018
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lindsay Standeven, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774641
- Sponsor's protocol ID
- IRB00162134
- Other IDs
- 1R01AG058671
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2018
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Viguera AC, Whitfield T, Baldessarini RJ, Newport DJ, Stowe Z, Reminick A, Zurick A, Cohen LS. Risk of recurrence in women with bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation. Am J Psychiatry. 2007 Dec;164(12):1817-24; quiz 1923. doi: 10.1176/appi.ajp.2007.06101639.
PubMed 18056236Newport DJ, Stowe ZN, Viguera AC, Calamaras MR, Juric S, Knight B, Pennell PB, Baldessarini RJ. Lamotrigine in bipolar disorder: efficacy during pregnancy. Bipolar Disord. 2008 May;10(3):432-6. doi: 10.1111/j.1399-5618.2007.00565.x.
PubMed 18402631Le Strat Y, Dubertret C, Le Foll B. Prevalence and correlates of major depressive episode in pregnant and postpartum women in the United States. J Affect Disord. 2011 Dec;135(1-3):128-38. doi: 10.1016/j.jad.2011.07.004. Epub 2011 Jul 29.
PubMed 21802737Barker ED, Kirkham N, Ng J, Jensen SK. Prenatal maternal depression symptoms and nutrition, and child cognitive function. Br J Psychiatry. 2013 Dec;203(6):417-21. doi: 10.1192/bjp.bp.113.129486. Epub 2013 Oct 10.
PubMed 24115347McPhie S, Skouteris H, Fuller-Tyszkiewicz M, Hill B, Jacka F, O'Neil A. Relationships between mental health symptoms and body mass index in women with and without excessive weight gain during pregnancy. Midwifery. 2015 Jan;31(1):138-46. doi: 10.1016/j.midw.2014.07.004. Epub 2014 Jul 19.
PubMed 25086989Kim HG, Mandell M, Crandall C, Kuskowski MA, Dieperink B, Buchberger RL. Antenatal psychiatric illness and adequacy of prenatal care in an ethnically diverse inner-city obstetric population. Arch Womens Ment Health. 2006 Mar;9(2):103-7. doi: 10.1007/s00737-005-0117-5. Epub 2005 Dec 29.
PubMed 16380813Grigoriadis S, VonderPorten EH, Mamisashvili L, Tomlinson G, Dennis CL, Koren G, Steiner M, Mousmanis P, Cheung A, Radford K, Martinovic J, Ross LE. The impact of maternal depression during pregnancy on perinatal outcomes: a systematic review and meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):e321-41. doi: 10.4088/JCP.12r07968.
PubMed 23656857Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
PubMed 19336362Diego MA, Field T, Hernandez-Reif M, Cullen C, Schanberg S, Kuhn C. Prepartum, postpartum, and chronic depression effects on newborns. Psychiatry. 2004 Spring;67(1):63-80. doi: 10.1521/psyc.67.1.63.31251.
PubMed 15139586Ashman SB, Dawson G, Panagiotides H, Yamada E, Wilkinson CW. Stress hormone levels of children of depressed mothers. Dev Psychopathol. 2002 Spring;14(2):333-49. doi: 10.1017/s0954579402002080.
PubMed 12030695Essex MJ, Klein MH, Cho E, Kalin NH. Maternal stress beginning in infancy may sensitize children to later stress exposure: effects on cortisol and behavior. Biol Psychiatry. 2002 Oct 15;52(8):776-84. doi: 10.1016/s0006-3223(02)01553-6.
PubMed 12372649Halligan SL, Herbert J, Goodyer IM, Murray L. Exposure to postnatal depression predicts elevated cortisol in adolescent offspring. Biol Psychiatry. 2004 Feb 15;55(4):376-81. doi: 10.1016/j.biopsych.2003.09.013.
PubMed 14960290Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
PubMed 15234824Akman I, Kuscu K, Ozdemir N, Yurdakul Z, Solakoglu M, Orhan L, Karabekiroglu A, Ozek E. Mothers' postpartum psychological adjustment and infantile colic. Arch Dis Child. 2006 May;91(5):417-9. doi: 10.1136/adc.2005.083790. Epub 2006 Feb 1.
PubMed 16452109Flynn HA, Davis M, Marcus SM, Cunningham R, Blow FC. Rates of maternal depression in pediatric emergency department and relationship to child service utilization. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):316-22. doi: 10.1016/j.genhosppsych.2004.03.009.
PubMed 15234828
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women
- ClinicalTrials.gov ID
- NCT03774641
- Acronym / sponsor ID
- IRB00162134
- Keywords
- Lamotrigine, Bipolar Disorder, Major Depressive Disorder, Schizo Affective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 13 Dec 2018 (actual)
- 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.
Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.
Detailed description
Studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. However, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. One likely explanation for the high relapse rate of Bipolar Disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. Pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. Therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. Therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. Most pregnant psychiatric patients are therefore managed based on symptom recurrence. In contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. The investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with Bipolar Disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. In the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taking Lamotrigine | – | Drug: LamictalLamotrigine (Lamictal), dosage will be based on a reference concentration of blood-serum levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who are currently taking Lamotrigine for Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder, or another psychiatric illness, and plan to continue throughout pregnancy.
Key inclusion criteria (4 listed)
- pregnant, prior or 20 weeks
- currently taking Lamotrigine and plan to continue throughout pregnancy
- history of Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder or other psychiatric illness, currently stable
- may be taking other psychiatric medications
Key exclusion criteria (2 listed)
- suicidal/clinically unstable
- alcohol, marijuana, or other drug dependence in last 90 days
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 |
|---|---|---|
| LamictalAlso: LamotrigineBlood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained | Drug | Taking Lamotrigine |
Primary outcome
Change in Mood as assessed by The Edinburgh Postnatal Rating Scale
Time frame: Monthly, after enrollment, up to 10 months
Self-reported experience of depressive symptoms over the past 7 days, each item is scored 0-3 (0=not experiencing the symptom, 3=experiencing the symptom most of the time) yielding a total between 0 and 30. A score of 0-9 indicates little to no depressive symptoms and a score from 10-30 indicates significant depressive symptoms.
Change in Mood as assessed by The Young Mania Rating Scale
Time frame: Monthly, after enrollment, up to 10 months
Clinical interview that measures manic symptoms in the past 2 weeks, each item is scored 0-4 (0=absent, 4=fully present) yielding a total between 0 and 44. Any score above 0 indicates a possible manic episode.
Side Effect as assessed by the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale
Time frame: Monthly, after enrollment, up to 10 months
Clinical interview that measures current, or in the past 72 hours, side effects of medication, each item is scored 0-3 (0=not or doubtfully present, 3=severe), yielding a total between 0 and 168. Any score above 0 indicates a possible causal relationship between medication and side effects.
Side Effect as assessed by the Frequency, Intensity, and Burden of Side Effects Rating Scale
Time frame: Monthly, after enrollment, up to 10 months
Self-reported frequency, intensity, and burden of side effects in the past week, each item is scored 0-6 (0=no side effects/impairment, 6=present all the time/intolerable/unable to function) yielding a total between 0 and 18. For each item, a score of 0-2 indicates treatment should continue, a score of 3-4 indicates the side effect should be addressed, and a score of 5-6 indicates a change in treatment is needed.
Change in Infant Habituation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's ability to shut down response to a stimulus, the item is scored 1-9, a low score indicates no decrement in response over 10 stimuli and a high score indicates a shut down of response after 1-2 stimuli
Change in Infant Attention as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's response to a stimulus, the item is scored 1-9, a low score indicates no response and a high score indicates alerting to stimulus
Change in Infant Self-Regulation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's ability to self-regulate, the item is scored 1-9, a low score indicates the infant makes no attempt to quiet self and a high score indicates the infant consistently quiets self for sustained periods
Change in Infant Arousal as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's arousal, the item is scored 1-9, a low score indicates a low level of arousal to all stimuli and a high score indicates the infant achieves insulated crying
Change in Infant Tonicity as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's body tone, the item is scored 1-9, a low score indicates the infant is flaccid and a high score indicates the infant is hypertonic
Change in Infant Reflexes as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's reflexes, the item is scored 1-5, a low score indicates no response and a high score indicates a strong response
Change in Infant Quality of Movement as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
Time frame: At 1, 2, 4, and 6 weeks postpartum
Neurobehavioral assessment measuring infant's power and flexibility, the item is scored 1-5, a low score indicates no resistance/movement and a high score indicates strong resistance/movement
Gestational Age at Birth in Weeks assessed by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
Birth Length in Inches assessed by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
Birth Weight in pounds assessed by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
APGAR Score at 1 Minute assessed by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
APGAR Score at 5 Minutes assessed by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
Assessment of Neonatal Intensive Care Unit Admission by Review of the Infant Delivery Chart
Time frame: At 2 weeks postpartum visit, up to 15 minutes
By reviewing the infant delivery chart, the outcome will be "yes" if the infant was admitted to the Neonatal Intensive Care Unit and "no" if the infant was not admitted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Background: PubMed 18056236Viguera AC, Whitfield T, Baldessarini RJ, Newport DJ, Stowe Z, Reminick A, Zurick A, Cohen LS. Risk of recurrence in women with bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation. Am J Psychiatry. 2007 Dec;164(12):1817-24; quiz 1923. doi: 10.1176/appi.ajp.2007.06101639.
- Background: PubMed 18402631Newport DJ, Stowe ZN, Viguera AC, Calamaras MR, Juric S, Knight B, Pennell PB, Baldessarini RJ. Lamotrigine in bipolar disorder: efficacy during pregnancy. Bipolar Disord. 2008 May;10(3):432-6. doi: 10.1111/j.1399-5618.2007.00565.x.
- Background: PubMed 21802737Le Strat Y, Dubertret C, Le Foll B. Prevalence and correlates of major depressive episode in pregnant and postpartum women in the United States. J Affect Disord. 2011 Dec;135(1-3):128-38. doi: 10.1016/j.jad.2011.07.004. Epub 2011 Jul 29.
- Background: PubMed 24115347Barker ED, Kirkham N, Ng J, Jensen SK. Prenatal maternal depression symptoms and nutrition, and child cognitive function. Br J Psychiatry. 2013 Dec;203(6):417-21. doi: 10.1192/bjp.bp.113.129486. Epub 2013 Oct 10.
- Background: PubMed 25086989McPhie S, Skouteris H, Fuller-Tyszkiewicz M, Hill B, Jacka F, O'Neil A. Relationships between mental health symptoms and body mass index in women with and without excessive weight gain during pregnancy. Midwifery. 2015 Jan;31(1):138-46. doi: 10.1016/j.midw.2014.07.004. Epub 2014 Jul 19.
- Background: PubMed 16380813Kim HG, Mandell M, Crandall C, Kuskowski MA, Dieperink B, Buchberger RL. Antenatal psychiatric illness and adequacy of prenatal care in an ethnically diverse inner-city obstetric population. Arch Womens Ment Health. 2006 Mar;9(2):103-7. doi: 10.1007/s00737-005-0117-5. Epub 2005 Dec 29.
- Background: PubMed 23656857Grigoriadis S, VonderPorten EH, Mamisashvili L, Tomlinson G, Dennis CL, Koren G, Steiner M, Mousmanis P, Cheung A, Radford K, Martinovic J, Ross LE. The impact of maternal depression during pregnancy on perinatal outcomes: a systematic review and meta-analysis. J Clin Psychiatry. 2013 Apr;74(4):e321-41. doi: 10.4088/JCP.12r07968.
- Background: PubMed 19336362Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
- Background: PubMed 15139586Diego MA, Field T, Hernandez-Reif M, Cullen C, Schanberg S, Kuhn C. Prepartum, postpartum, and chronic depression effects on newborns. Psychiatry. 2004 Spring;67(1):63-80. doi: 10.1521/psyc.67.1.63.31251.
- Background: PubMed 12030695Ashman SB, Dawson G, Panagiotides H, Yamada E, Wilkinson CW. Stress hormone levels of children of depressed mothers. Dev Psychopathol. 2002 Spring;14(2):333-49. doi: 10.1017/s0954579402002080.
- Background: PubMed 12372649Essex MJ, Klein MH, Cho E, Kalin NH. Maternal stress beginning in infancy may sensitize children to later stress exposure: effects on cortisol and behavior. Biol Psychiatry. 2002 Oct 15;52(8):776-84. doi: 10.1016/s0006-3223(02)01553-6.
- Background: PubMed 14960290Halligan SL, Herbert J, Goodyer IM, Murray L. Exposure to postnatal depression predicts elevated cortisol in adolescent offspring. Biol Psychiatry. 2004 Feb 15;55(4):376-81. doi: 10.1016/j.biopsych.2003.09.013.
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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.
Lindsay Standeven, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Major Depressive Disorder, run by Johns Hopkins University at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2025. 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 United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mood as assessed by The Edinburgh Postnatal Rating Scale (time frame: Monthly, after enrollment, up to 10 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774641, which also lists 23 linked publications.
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 5 Mar 2025.