Postpartum DepressionNCT01527448
Quetiapine in the Treatment of Postpartum Depression (PPD) in Bipolar Disorder (BD), Type II
A study testing Quetiapine XR (seroquel) in people with Postpartum Depression, run by BC Women's Hospital & Health Centre at 1 site in Canada.
Trial summary
This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to 8 times over a period of 9 weeks. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Quetiapine XR (seroquel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jul 2010
- Phase
- Interventional
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- signed informed consent;
- women, 19 - 40 years;
- meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria of Bipolar II Disorder (confirmed by Mini International Neuropsychiatric Interview (MINI));
- Hamilton Depression Rating Scale (HAM-D) (17-item) total score of > 22 and HAM-D item 1 (depressed mood) score of >2 at Visit 1 (enrolment) \& Visit 2;
- negative serum pregnancy test at enrolment, use reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during study;
- understand and comply with requirements of study
- outpatient status at enrolment.
Who cannot join
- DSM-IV Axis I disorder other than Bipolar II Disorder within 6 months of enrolment;
- diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status;
- substance or alcohol abuse or dependence within 6 months prior to enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV criteria;
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment;
- use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 3A4 enzymes within 2 weeks prior to Visit 2;
- pregnancy or lactation;
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- evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS);
- clinical finding that is unstable or inadequately treated, (e.g., hypertension, poorly controlled diabetes, unstable angina) or that would be negatively affected by the study medication or affect the study medication;
- medical conditions that would affect absorption, distribution, metabolism, or excretion of study medication (e.g., malabsorption syndrome, liver disease);
- current diagnosis of cancer (except basal or squamous cell skin carcinoma) unless in remission for at least 5 years;
- current or past diagnosis of stroke or Transient Ischemic Attacks (TIA);
- history of seizure disorder, except febrile convulsions;
- receipt of electroconvulsive therapy (ECT) within 90 days prior to Visit 2;
- use of antipsychotic, mood stabilizer, or antidepressant drugs within 7 days before Visit 2, or use of fluoxetine within 28 days before Visit 2, or use of monoamine oxidase inhibitors (MAOIs), anxiolytic or hypnotics within 14 days before Visit 2 (with the exception of those allowed with restriction per protocol), or use of a depot antipsychotic injection within 2 dosing interval before Visit 2;
- subjects who will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to Visit 2;
- subjects who pose a current serious suicidal or homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months;
- a patient with Diabetes Mellitus (DM) fulfilling specific criteria as judged by the investigator that would make her unable to participate;
- clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator;
- an absolute neutrophil count (ANC) of <1.5 x 109 per liter;
- a thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism;
- liver function tests aspartate aminotransferase (AST) or alanine aminotransferase (ALT) three times the upper normal limit;
- Electrocardiogram (ECG) results considered being clinically significant based on assessment by a centrally located experienced cardiologist interpreting the ECG;
- use of quetiapine in doses greater than 25mg/day for insomnia within 7 days before Visit 2;
- known history of intolerance or hypersensitivity to quetiapine;
- known lack of response to quetiapine in the treatment of depression in a dosage of at least 50 mg per day for 4 weeks (at any time before study start);
- treatment with quetiapine with a dosage of at least 50 mg/day at Visit 1 (enrolment);
- contraindications as detailed in the country-specific prescribing information for quetiapine;
- involvement in the planning and conduct of the study;
- previous enrolment in any AstraZeneca-sponsored study with quetiapine;
- participation in another clinical study or compassionate use programme within 4 weeks of Visit 2 or longer in accordance with local requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Dose Titration Study of Quetiapine XR in the Treatment of Postpartum Depression in Nonlactating Women Diagnosed With Bipolar Disorder (BD), Type II.
This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to 8 times over a period of 9 weeks.
During the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg.
Read the detailed description
This study will help clinicians increase their awareness of the existence of Bipolar II Disorder in the perinatal population and provide guidance in terms of appropriate treatment. Since this diagnosis in the postpartum population is done by elimination, this study will provide evidence of the merits of identifying and treating this order on time. When selective serotonin reuptake inhibitors (SSRIs) fail for symptom relief in women diagnosed with unipolar depression, postpartum onset, clinicians tend to either augment or combine a variety of psychotropic medications for treatment response. It is probably likely that these patients are Bipolar II Disorder who continue to cycle through the treatment. Adding an atypical antipsychotic is often an afterthought. Therefore, the unique aspects of treating this specific population right at the outset when a diagnosis of mood disorders is made is optimal. Clinicians not only need to actively consider bipolar type II in their differential diagnosis, but also to initiate treatment as soon as possible to relieve further suffering. This study will help diagnose postpartum Bipolar II Disorder and test the unique action of quetiapine with its mood stabilizing and antidepressant properties.
Hypothesis:
Quetiapine XR will be effective in the treatment of postpartum depression in women with Bipolar II Disorder.
- Conditions
- Postpartum Depression
- Being tested
- Quetiapine XR (seroquel)
- Keywords
- postpartum, postpartum depression, PPD, quetiapine XR, quetiapine, seroquel, bipolar, bipolar disorder, bipolar disorder, type II
- Medical subject headings
- Depression, Postpartum, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XR (seroquel)Drug
Also called Seroquel XR
During the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg.
| Study group | Role | What they receive |
|---|---|---|
| Atypical antipsychotic treatment | Experimental | Quetiapine XR is given to postpartum women diagnosed with bipolar disorder II. Starting dose is 50mg, maximum dose is 300mg/day. Receives: Drug: Quetiapine XR (seroquel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).
Measured: The primary variable is the change from Week 0 to Week 8 in the MADRS score
Secondary outcomes (3)
To evaluate if Quetiapine XR improves the health relate quality of life of postpartum depression in non-lactating women with Bipolar II Disorder
Measured: Change from Week 0 to Week 8 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score. Change from Week 0 to Week 8 in Q-LES-Q Item 16 (Overall quality of life) score.
To evaluate if Quetiapine XR improves satisfaction with medication in postpartum depression in non-lactating women with Bipolar II Disorder.
Measured: Change from Week 0 to Week 8 in Q-LES-Q Item 15 (Satisfaction with medication) score.
To evaluate if Quetiapine XR improves sleep quality in postpartum depression in non-lactating women with Bipolar II Disorder.
Measured: Change from Week 0 to Week 8 in Pittsburgh Sleep Quality Index (PSQI) global score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startApr 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- BC Women's Hospital & Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shaila Misri, BC Women's Hospital & Health Centre
- Investigators
- Shaila Misri, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527448
- Sponsor's protocol ID
- D1443L00032
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Titration Study of Quetiapine XR in the Treatment of Postpartum Depression in Nonlactating Women Diagnosed With Bipolar Disorder (BD), Type II.
- ClinicalTrials.gov ID
- NCT01527448
- Acronym / sponsor ID
- D1443L00032
- Conditions
- Postpartum Depression
- Keywords
- postpartum, postpartum depression, PPD, quetiapine XR, quetiapine, seroquel, bipolar, bipolar disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BC Women's Hospital & Health CentreUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Feb 2012 (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 is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to 8 times over a period of 9 weeks.
During the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg.
Detailed description
This study will help clinicians increase their awareness of the existence of Bipolar II Disorder in the perinatal population and provide guidance in terms of appropriate treatment. Since this diagnosis in the postpartum population is done by elimination, this study will provide evidence of the merits of identifying and treating this order on time. When selective serotonin reuptake inhibitors (SSRIs) fail for symptom relief in women diagnosed with unipolar depression, postpartum onset, clinicians tend to either augment or combine a variety of psychotropic medications for treatment response. It is probably likely that these patients are Bipolar II Disorder who continue to cycle through the treatment. Adding an atypical antipsychotic is often an afterthought. Therefore, the unique aspects of treating this specific population right at the outset when a diagnosis of mood disorders is made is optimal. Clinicians not only need to actively consider bipolar type II in their differential diagnosis, but also to initiate treatment as soon as possible to relieve further suffering. This study will help diagnose postpartum Bipolar II Disorder and test the unique action of quetiapine with its mood stabilizing and antidepressant properties.
Hypothesis:
Quetiapine XR will be effective in the treatment of postpartum depression in women with Bipolar II Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atypical antipsychotic treatment | Experimental | Drug: Quetiapine XR (seroquel)Quetiapine XR is given to postpartum women diagnosed with bipolar disorder II. Starting dose is 50mg, maximum dose is 300mg/day. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- signed informed consent;
- women, 19 - 40 years;
- meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria of Bipolar II Disorder (confirmed by Mini International Neuropsychiatric Interview (MINI));
- Hamilton Depression Rating Scale (HAM-D) (17-item) total score of > 22 and HAM-D item 1 (depressed mood) score of >2 at Visit 1 (enrolment) \& Visit 2;
- negative serum pregnancy test at enrolment, use reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during study;
Key exclusion criteria (30 listed)
- DSM-IV Axis I disorder other than Bipolar II Disorder within 6 months of enrolment;
- diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status;
- substance or alcohol abuse or dependence within 6 months prior to enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV criteria;
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment;
- use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 3A4 enzymes within 2 weeks prior to Visit 2;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine XR (seroquel)Also: Seroquel XRDuring the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg. | Drug | Atypical antipsychotic treatment |
Primary outcome
The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: The primary variable is the change from Week 0 to Week 8 in the MADRS score
3 secondary outcomes
To evaluate if Quetiapine XR improves the health relate quality of life of postpartum depression in non-lactating women with Bipolar II Disorder
Time frame: Change from Week 0 to Week 8 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score. Change from Week 0 to Week 8 in Q-LES-Q Item 16 (Overall quality of life) score.
To evaluate if Quetiapine XR improves satisfaction with medication in postpartum depression in non-lactating women with Bipolar II Disorder.
Time frame: Change from Week 0 to Week 8 in Q-LES-Q Item 15 (Satisfaction with medication) score.
To evaluate if Quetiapine XR improves sleep quality in postpartum depression in non-lactating women with Bipolar II Disorder.
Time frame: Change from Week 0 to Week 8 in Pittsburgh Sleep Quality Index (PSQI) global score.
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 10 Feb 2012.
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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.
Shaila Misri, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quetiapine XR (seroquel) in people with Postpartum Depression, run by BC Women's Hospital & Health Centre at 1 site in Canada.
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 7 inclusion and 30 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 10 Feb 2012. 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 Canada. 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?
The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS). (time frame: The primary variable is the change from Week 0 to Week 8 in the MADRS score). 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 10 Feb 2012.