Pregnant Women Taking Lamictal for Bipolar Disorder

NCT01996293 | Completed

• 1 other identifier: 00079810
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum. Because the concentration of the medication is likely to decrease during pregnancy, it is important for doctors to know how much they should increase a patient's dose in order to prevent worsening of Bipolar symptoms. In this study, the investigators will ask that participants complete up to five overnight visits to our clinical research unit where their blood will be drawn every couple of hours, through an IV catheter, to measure how the concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated for their time.

Conditions

Bipolar Disorder

Keywords

pregnant; bipolar; lamotrigine; lamictal; women; female

Outcome Measures

Primary Outcomes (1)

• Change in Serum concentration/elimination

  For patients on 1x day dosing, serum levels will be obtained beginning at time 0 and at hours, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24 and L/D ratio will be determined at each time point. This series of serum levels will be completed an average of every 10 weeks across pregnancy, and postpartum. For patients on 2x dosing, serum levels will be obtained at hours 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 13.5, 14.5, and 16 hours.

  An average of every 10 weeks; Hours 0, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, or 0, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 13.5, 14.5, and 16

Secondary Outcomes (4)

• Infant (umbilical cord)/Maternal ratio of LTG

  30 min

• Scores on depression assessment, Inventory of Depression Symptomatology- Self Report (IDS-SR)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum.

• Scores on mania assessment, Young Mania Reporting Scale (YMRS)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum.

• Scores on anxiety scale, Generalized Anxiety Disorder (GAD-7)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum.

Other Outcomes (1)

• Percent increase in estradiol levels and their correlation to percent decrease in LTG L/D ratio

  Estradiol levels will be examined an average of every 10 weeks from the time the participant enters the study, up to 12 weeks postpartum.

Study Arms (1)

Lamotrigine for Bipolar

antepartum and peripartum women taking lamotrigine for Bipolar Disorder

Drug: lamotrigine

Interventions

lamotrigine DRUG

Lamotrigine will be observed in women who have already under the guidance of a physician decide to continue lamotrigine for the treatment of Bipolar Disorder

Also known as: Lamictal, Lamiktal, Labileno, Triazines

Lamotrigine for Bipolar

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited broadly from Northwestern clinical services including Internal Medicine, OB/GYN, Family Medicine, and Psychiatry, registries, and from the local Chicagoland community. Patients that sign consent, complete the evaluation and meet criteria for Bipolar Disorder, any subtype, will be enrolled into the study.

You may qualify if:

• Age 18 or older
• If Pregnant, equal to or less than 26 weeks
• English-speaking
• DSM-IV Bipolar Disorder, any subtype
• Able to provide informed consent
• Daily dosing of Lamictal

You may not qualify if:

• Active substance abuse within last 6 months and/or positive urine drug screen
• Active suicidality
• No obstetrical care
• Antiepileptic drugs that affect metabolism of LTG
• Medications in FDA categories F or X that are not antimanic drugs
• Liver or kidney disease

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Clark CT, Klein AM, Perel JM, Helsel J, Wisner KL. Lamotrigine dosing for pregnant patients with bipolar disorder. Am J Psychiatry. 2013 Nov;170(11):1240-7. doi: 10.1176/appi.ajp.2013.13010006.

  PMID: 24185239 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum specimen will be obtained to measure lamotrigine and estradiol levels. Standard of care labs will be obtained on every participant that is eligible and signs informed consent. Participants will not have more than 50 ml of blood drawn every 8 weeks. Participants will also have the option to have blood drawn for DNA banking. Participants in the study that elect to receive analgesia for pain related to labor and have a spinal-epidural at Northwestern University will have CSF stored and banked for future analysis.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine; Triazines

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Crystal T Clark, MD, MSc

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 27, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)