Reproductive Function in Women With Bipolar Disorder

Status Recruiting

Clinical Trial Summary

Many studies have shown that patients with bipolar disorder are prone to reproductive dysfunction, including polycystic ovary syndrome, hyperprolactinemia, and amenorrhea. However, there is still considerable disagreement about the causes of reproductive dysfunction in patients with bipolar disorder. This study will evaluate the reproductive function of female patients with bipolar disorder without medication and those with bipolar disorder after stable medication, compared with the health control. The purpose of the study is to explore the influence, degree, and possible risk factors of bipolar disorder itself and drugs on the reproductive function of female patients.

Clinical Trial Description

This study will comprise 60 female patients with bipolar disorder without medication, 60 female patients with bipolar disorder after stable prescription for ≥6 months, and 60 age and BMI-matched healthy controls. All of whom gave informed consent. All participants will be assessed and clinically examined at baseline, and all patients are encouraged to follow up in the sixth month. Baseline assessments will include demographics, menstrual records, comprehensive medical history, anthropometric measurements (weight and height), physical examination, pelvic ultrasound, and laboratory work (e.g., reproductive hormones). The follow-up of patients will include menstrual records, pelvic ultrasound, and reproductive hormones. Clinical symptoms will be assessed by Hamilton Depression Scale, Hamilton Anxiety Scale, and Young Mania Rating Scale at baseline and week 24. The cognitive function will be assessed at baseline and the sixth month with the Reusable Assessment of Neuropsychological Status Battery (RBANS) and the Stroop Color-Word Test. The primary outcomes will be menstruation, reproductive hormone levels, and pelvic ultrasound. Secondary outcomes will include overall psychiatric symptomatology, quality of life, cognitive function, and other biological data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05307848
Study type	Observational [Patient Registry]
Source	Central South University
Contact	Jindong Chen, M.D. Ph.D
Phone	+8613807319266
Email	chenjindong@csu.edu.cn
Status	Recruiting
Phase
Start date	March 1, 2021
Completion date	February 28, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT02855762` - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder	N/A
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Completed	`NCT02513654` - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects	Phase 1
Recruiting	`NCT06313918` - Exercise Therapy in Mental Disorders-study	N/A
Completed	`NCT02304432` - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine	Early Phase 1
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT02212041` - Electronic Cigarettes in Smokers With Mental Illness	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Not yet recruiting	`NCT04432116` - Time and Virtual Reality in Schizophrenia and Bipolar Disorder	N/A
Terminated	`NCT02893371` - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated	`NCT02909504` - Gao NARASD Lithium Study	Phase 4
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting	`NCT02481245` - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study	Phase 2
Recruiting	`NCT03088657` - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.