Quetiapine in the Treatment of Postpartum Depression (PPD) in Bipolar Disorder (BD), Type II

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Shaila Misri, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier:
NCT01527448
First received: February 3, 2012
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Postpartum Depression
Drug: Quetiapine XR (seroquel)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by BC Women's Hospital & Health Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atypical antipsychotic treatment
Quetiapine XR is given to postpartum women diagnosed with bipolar disorder II. Starting dose is 50mg, maximum dose is 300mg/day.
Drug: Quetiapine XR (seroquel)
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.
Other Name: Seroquel XR

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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527448

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
BC Women's Hospital & Health Centre
Investigators
Principal Investigator: Shaila Misri, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Shaila Misri, Principal Investigator, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier: NCT01527448     History of Changes
Other Study ID Numbers: D1443L00032
Study First Received: February 3, 2012
Last Updated: February 9, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by BC Women's Hospital & Health Centre:
postpartum
postpartum depression
PPD
quetiapine XR
quetiapine
seroquel
bipolar
bipolar disorder
bipolar disorder, type II

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pregnancy Complications
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014