Reproductive Function and Mood in Women With Bipolar Disorder
Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Bipolar disorder is a serious condition that can have devastating effects on social and psychological functioning. Evidence suggests that medications for bipolar disorder may influence reproduction function among women. This study will determine reproductive function and mood changes in women who are currently on medication for bipolar disorder.
This study will comprise women with bipolar disorder and age- and body mass index (BMI)-matched healthy controls. Participants will have their reproductive function and mood changes assessed for 3 consecutive menstrual cycles. Daily, participants will report about their mood, sleep patterns, life events, and any psychiatric medications; this information will be entered into a computerized system named ChronoRecord. In addition, participants will measure their basal body temperature and collect their urine every morning to assess for ovulation. Blood collection will occur at study entry and between Days 3 and 6 of every menstrual cycle to determine levels of reproductive hormones. Participants will be asked to fast for 12 hours prior to every blood collection. During the first month of the study, an extra study visit will occur. Participants will undergo a physical exam for determination of excessive hair growth (hirsutism) and BMI. Additionally, insulin resistance will be measured, and participants will be asked to complete a questionnaire that will be used to determine their past and current menstrual function, as well as the reproductive and psychiatric history of their families.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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California
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Stanford, California, Förenta staterna, 94305
- Stanford University School of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria for All Participants:
- Have been menstruating for at least 4 years prior to study entry
- Participants must be willing to travel to Stanford University at own expense for study visits
Inclusion Criteria for Bipolar Disorder Participants:
- Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS), and be under the treatment of a physician who can be contacted in case of an emergency
- Current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic)
Inclusion Criteria for Healthy Controls:
- No past or present diagnosis of mental illness
Exclusion Criteria for All Participants:
- Current alcohol or substance abuse or dependence within 6 months prior to study entry
- Meets criteria for another DSM-IV Axis I disorder
- Contraceptive steroid use within 3 months prior to study entry
- Current use of medication that may affect steroid metabolism
- Menopausal
- Endocrine disease such as diabetes or hypothyroidism
- Uncontrolled medical illness
- History of long-term corticosteroid use
- Organic mood disorder
- Pregnancy or breastfeeding within 3 months prior to study entry
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Ekologisk eller gemenskap
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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1
Women with bipolar disorder
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2
Women who are healthy controls
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Natalie L. Rasgon, MD, PhD, Department of Psychiatry and Behavioral Sciences, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01MH066033 (U.S.S. NIH-anslag/kontrakt)
- SPO# 28571
- DAHBR 96-BHC (Annat bidrag/finansieringsnummer: National Institute of Mental Health (NIMH))
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