Lithium Therapy: Understanding Mothers, Metabolism and Mood
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | May 2019 |
| Contact: | Rebecca L Newmark, BA |
| Email: | rebecca.newmark@northwestern.edu |
| Phone: | 3126956010 |
Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation
to medication therapy for Major Depression, is commonly continued in pregnancy due to its
therapeutic benefit and more recent data that suggests the teratogenic effects of lithium
are less than historically believed. Due to the increased elimination of lithium during
pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to
BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the
risk for postpartum exacerbation of BD and psychosis. Our study will investigate the
pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum.
Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium
will be invited to participate in a study to measure repeated blood levels of lithium at six
time points between preconception and 3 months postpartum. The data collected will inform
the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer
untoward effects for the mother and baby. Change in elimination clearance of lithium will be
correlated with symptom worsening to develop a dosing algorithm that will help maintain
wellness for pregnant women with mood disorders.
to medication therapy for Major Depression, is commonly continued in pregnancy due to its
therapeutic benefit and more recent data that suggests the teratogenic effects of lithium
are less than historically believed. Due to the increased elimination of lithium during
pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to
BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the
risk for postpartum exacerbation of BD and psychosis. Our study will investigate the
pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum.
Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium
will be invited to participate in a study to measure repeated blood levels of lithium at six
time points between preconception and 3 months postpartum. The data collected will inform
the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer
untoward effects for the mother and baby. Change in elimination clearance of lithium will be
correlated with symptom worsening to develop a dosing algorithm that will help maintain
wellness for pregnant women with mood disorders.
There is an increased risk of recurrence of Bipolar Disorder (BD) episodes or worsening
symptoms in pregnancy after the discontinuation of mood stabilizers. Similarly, changes in
medication concentration due to the physiological changes in pregnancy may effectively
reduce the medication dose and thus its efficacy in pregnancy. Therapeutic dose monitoring
has proven to have great utility in preventing seizure recurrence in women with epilepsy
(WWE). Similar guidelines to that of women with epilepsy would benefit pregnant women with
BD who are taking mood stabilizing medications in pregnancy. Current evidence suggests that
lithium has a more favorable reproductive profile than many mood stabilizing antiepileptic
agents. However, the pharmacokinetics as well as the utility of therapeutic dose monitoring
of lithium in pregnant patients with Bipolar Disorder has not been well studied.
This study is an observational protocol to explore the longitudinal pharmacokinetics (PK) of
lithium during pregnancy and postpartum in 20 women with Bipolar Disorder. The correlation
between changes in bioavailability and concentrations ratios and increases in symptoms of
depression, mania and anxiety and recurrence of syndromal BD episodes that fulfill
Diagnostic and Statistics Manual of Mental Disorders (IV) (DSM4) criteria will be
investigated.
The primary aims of this study are 1.) To describe the changes in lithium elimination and
serum concentration across pregnancy and postpartum to establish its efficacious use and
dosing requirements during childbearing 2.) To evaluate the associations between maternal
and umbilical cord lithium serum levels. 3.) To explore the relationship between declining
lithium serum concentrations during pregnancy and the increase in psychiatric symptoms and
recurrence of syndromal BD.
To optimize the research yield from this investigation, participants will have the option to
allow banking of cerebrospinal (CSF) fluid and DNA for future analyses.
symptoms in pregnancy after the discontinuation of mood stabilizers. Similarly, changes in
medication concentration due to the physiological changes in pregnancy may effectively
reduce the medication dose and thus its efficacy in pregnancy. Therapeutic dose monitoring
has proven to have great utility in preventing seizure recurrence in women with epilepsy
(WWE). Similar guidelines to that of women with epilepsy would benefit pregnant women with
BD who are taking mood stabilizing medications in pregnancy. Current evidence suggests that
lithium has a more favorable reproductive profile than many mood stabilizing antiepileptic
agents. However, the pharmacokinetics as well as the utility of therapeutic dose monitoring
of lithium in pregnant patients with Bipolar Disorder has not been well studied.
This study is an observational protocol to explore the longitudinal pharmacokinetics (PK) of
lithium during pregnancy and postpartum in 20 women with Bipolar Disorder. The correlation
between changes in bioavailability and concentrations ratios and increases in symptoms of
depression, mania and anxiety and recurrence of syndromal BD episodes that fulfill
Diagnostic and Statistics Manual of Mental Disorders (IV) (DSM4) criteria will be
investigated.
The primary aims of this study are 1.) To describe the changes in lithium elimination and
serum concentration across pregnancy and postpartum to establish its efficacious use and
dosing requirements during childbearing 2.) To evaluate the associations between maternal
and umbilical cord lithium serum levels. 3.) To explore the relationship between declining
lithium serum concentrations during pregnancy and the increase in psychiatric symptoms and
recurrence of syndromal BD.
To optimize the research yield from this investigation, participants will have the option to
allow banking of cerebrospinal (CSF) fluid and DNA for future analyses.
Inclusion Criteria:
- Age 18 or older
- If Pregnant, equal to or less than 26 weeks
- English-speaking
- DSM-IV Bipolar Disorder, any subtype, Major Depressive Disorder, or Mood Disorder Not
Otherwise Specified
- Able to provide informed consent
- Daily dosing of lithium
Exclusion Criteria:
- Active substance abuse within last 6 months and/or positive urine drug screen
- Active suicidality
- No obstetrical care
- Use of other drugs that affect metabolism of lithium
- Medications in FDA categories F or X that are not antimanic drugs
- Chronic Kidney Disease
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Crystal T Clark, MD, MSc
Phone: 312-695-8648
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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