Quetiapine in the Treatment of Postpartum Depression (PPD) in Bipolar Disorder (BD), Type II
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

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.

      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.
    

Intervention name(s): Quetiapine XR (seroquel)
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postpartum; postpartum depression; PPD; quetiapine XR; quetiapine; seroquel; bipolar; bipolar disorder; bipolar disorder, type II