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

NCT01527448 | Completed

• 1 other identifier: D1443L00032
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression

Keywords

postpartum; postpartum depression; PPD; quetiapine XR; quetiapine; seroquel; bipolar; bipolar disorder; bipolar disorder, type II

Outcome Measures

Primary Outcomes (1)

• The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).

  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

  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.

  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.

  Change from Week 0 to Week 8 in Pittsburgh Sleep Quality Index (PSQI) global score.

Study Arms (1)

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.

Drug: Quetiapine XR (seroquel)

Interventions

Quetiapine XR (seroquel) DRUG

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.

Also known as: Seroquel XR

Atypical antipsychotic treatment

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• BC Women's Hospital & Health Centre: lead

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum; Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shaila Misri, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: April 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

CA (1)