Reproductive Function and Mood in Women With Bipolar Disorder
Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
California
-
Stanford, California, États-Unis, 94305
- Stanford University School of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Écologique ou communautaire
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
1
Women with bipolar disorder
|
|
2
Women who are healthy controls
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Natalie L. Rasgon, MD, PhD, Department of Psychiatry and Behavioral Sciences, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH066033 (Subvention/contrat des NIH des États-Unis)
- SPO# 28571
- DAHBR 96-BHC (Autre subvention/numéro de financement: National Institute of Mental Health (NIMH))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .