Bipolar DisorderNCT00183352
Reproductive Function and Mood in Women With Bipolar Disorder
An observational study of Bipolar Disorder and Mental Health, run by Stanford University at 1 site in United States.
Trial summary
This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Mental Health
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women diagnosed with Bipolar Disorder, between 18-40 years of age, who are currently treated with a mood stabilizing agent for a period of at least 3 months and are not taking birth control pills currently. Participants must be willing to travel to Stanford University (near San Francisco, CA) at their own expense for study visits.
Who may be able to join
- 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
- 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)
- No past or present diagnosis of mental illness
Who cannot join
- 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
Show all 10Show fewer
- Uncontrolled medical illness
- History of long-term corticosteroid use
- Organic mood disorder
- Pregnancy or breastfeeding within 3 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.
Read the detailed description
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.
- Conditions
- Bipolar Disorder, Mental Health
- Keywords
- Women, Mood, Menarche, Menstruation
- Medical subject headings
- Bipolar Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with bipolar disorder | |
| 2 | Women who are healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Natalie Rasgon, Stanford University
- Investigators
- Natalie L. Rasgon, MD, PhD, Principal investigator, Department of Psychiatry and Behavioral Sciences, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183352
- Sponsor's protocol ID
- R01MH066033
- Other IDs
- R01MH066033, SPO# 28571, DAHBR 96-BHC
- Status last verified
- Apr 2009
- First submitted
- 12 Sep 2005
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00183352
- Acronym / sponsor ID
- R01MH066033
- Conditions
- Bipolar Disorder, Mental Health
- Keywords
- Women, Mood, Menarche, Menstruation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with bipolar disorder |
| 2 | – | –Women who are healthy controls |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women diagnosed with Bipolar Disorder, between 18-40 years of age, who are currently treated with a mood stabilizing agent for a period of at least 3 months and are not taking birth control pills currently. Participants must be willing to travel to Stanford University (near San Francisco, CA) at their own expense for study visits.
Key inclusion criteria (5 listed)
- 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
- 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)
- No past or present diagnosis of mental illness
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie L. Rasgon, MD, PhD principal investigator
Department of Psychiatry and Behavioral Sciences, Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Mental Health, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.