NCT01527448

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: BC Women's Hospital & Health Centre · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2012-02-07
• Last updated: 2012-02-10

Locations

1 site across 1 country: Canada