Bipolar Affective DisordersNCT01385709
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
An observational study of Bipolar Affective Disorders and Cyclothymic Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2013
- 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
- No healthy volunteers
- Adult
Study population: The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium and sertraline are indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder.
Who may be able to join
- 18-40 year old female
- women currently taking Lithium or Sertraline
Who cannot join
- currently pregnant or breastfeeding
- concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera
- hepatic or renal disease
- irregular menstrual cycles.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.
- Conditions
- Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder
- Keywords
- Lithium, Sertraline
- Medical subject headings
- Cyclothymic Disorder, Psychotic Disorders, Depressive Disorder, Major, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Stress Disorders, Post-Traumatic, Premenstrual Dysphoric Disorder
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 |
|---|---|---|
| Sertraline | Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that sertraline is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking either sertraline on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles. | |
| Lithium | Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking lithium on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood levels of lithium or sertraline
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Measured: 5-9 days after menstrual cycle onset
Fluctuations in symptom severity
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
Measured: 5-9 days after onset of menstrual cycle
blood levels of lithium or sertraline
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Measured: 5-9 days before onset of next menstrual cycle
Fluctuations in symptom severity
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
Measured: 5-9 days before onset of next menstrual cycle
Secondary outcomes (2)
Correlations between Symptom Severity and Blood Levels of Drugs
Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.
Measured: 5-9 days after onset of menstrual cycle
Correlations between Symptom Severity and Blood Levels of Drugs
Determine whether there is a correlation between blood levels of lithium or sertraline and symptom severity during different phases of the menstrual cycle.
Measured: 5-9 days before onset of next menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisordersStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mallay B Occhiogrosso, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385709
- Sponsor's protocol ID
- 0310006393
- Status last verified
- Feb 2017
- First submitted
- 13 Jun 2011
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
- ClinicalTrials.gov ID
- NCT01385709
- Acronym / sponsor ID
- 0310006393
- Conditions
- Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder
- Keywords
- Lithium, Sertraline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Jun 2011 (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.
The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | – | –Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that sertraline is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking either sertraline on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles. |
| Lithium | – | –Therefore, patients who are already taking psychotropic medications, and therefore are currently in treatment for a psychiatric illness, will be recruited. The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium is indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. Patients must be female, between the ages of 18-40, taking lithium on a daily basis for at least one week. Exclusion criteria include 1) currently pregnant or breastfeeding, 2) concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera, 3) hepatic or renal disease, 4) irregular menstrual cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The specific psychiatric diagnoses anticipated in the subject pool include the conditions that lithium and sertraline are indicated to treat, including Bipolar Affective Disorders, Cyclothymic Disorder, Schizoaffective Disorder, Major Depressive Disorder, Dysthymic Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder.
Key inclusion criteria (2 listed)
- 18-40 year old female
- women currently taking Lithium or Sertraline
Key exclusion criteria (4 listed)
- currently pregnant or breastfeeding
- concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera
- hepatic or renal disease
- irregular menstrual cycles.
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
blood levels of lithium or sertraline
Time frame: 5-9 days after menstrual cycle onset
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Fluctuations in symptom severity
Time frame: 5-9 days after onset of menstrual cycle
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
blood levels of lithium or sertraline
Time frame: 5-9 days before onset of next menstrual cycle
Determine whether the blood levels of lithium or sertraline are affected by different phases of the menstrual cycle.
Fluctuations in symptom severity
Time frame: 5-9 days before onset of next menstrual cycle
Determine whether there is a fluctuation in symptom severity during different phases of the menstrual cycle.
2 secondary outcomes
Correlations between Symptom Severity and Blood Levels of Drugs
Time frame: 5-9 days after onset of menstrual cycle
Correlations between Symptom Severity and Blood Levels of Drugs
Time frame: 5-9 days before onset of next menstrual cycle
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 20 Feb 2017.
- Weill Cornell Medical College websiteLink provided by the sponsor.
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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.
Mallay B Occhiogrosso, M.D. principal investigator
Weill Medical College of Cornell 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 Affective Disorders and Cyclothymic Disorder, run by Weill Medical College of Cornell 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 2 inclusion and 4 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 20 Feb 2017. 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.
What does the primary outcome measure?
blood levels of lithium or sertraline (time frame: 5-9 days after menstrual cycle onset). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 20 Feb 2017.