Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients - SPaRCLe

• Conditions: Bipolar I Disorder; MedDRA version: 9.1Level: LLTClassification code 10004939Term: Bipolar I disorder

• Registration Number: EUCTR2004-000915-25-LT
• Lead Sponsor: AstraZeneca R&D Sodertalje

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

For inclusion in the Open-label Treatment Phase patients must fulfill all of the following criteria:
1. Provide written informed consent before initiation of any study-related procedures
2. A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most Recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
3. Male or female aged more than or equal to 18 years
4. At least 1 manic, depressed or mixed episode in the 2 years prior to the index episode
5. One of the following:
a. A current manic, depressed or mixed episode by DSM-IV criteria
b. A past manic, depressed or mixed episode within 26 weeks as documented by medical records, that was treated with quetiapine. Since this episode, treatment with quetiapine must not have been interrupted for more than 2 weeks continuously
6. Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
7. Able to understand and comply with the requirements of the study

For inclusion in the Randomized Treatment Phase, patients must fulfill all of the following criteria during the Open-label Treatment Phase:
1. Has been prescribed a dose of quetiapine within the range 300-800 mg/day for the last 4 weeks
2. YMRS less than or equal to 12 and MADRS less than or equal to 12 at all assessments during the last 4 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for entering the Open-label Treatment Phase
Any of the following is regarded as a criterion for exclusion from the study at enrollment:
1. Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year
2. Known intolerance or lack of response to quetiapine fumarate or to lithium, as judged by the investigator
3. Pregnancy or lactation. Female patients of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test at enrollment
4. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM IV criteria
5. Opiate, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir
7. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
8. Thyroid stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range, regardless of treatment for hypothyroidism or hyperthyroidism
9. Unstable or inadequately treated medical illness (e.g., angina pectoris and hypertension) as judged by the investigator
10. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrollment Glycosylated hemoglobin (HbA1c) >8.5%
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
- Not under care of physician responsible for patient’s DM care
- Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled
- Physician responsible for patient’s DM care has not approved patient’s participation in the study
- Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
Note: If a diabetic patient meets one of these criteria the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study
11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
12. Use of an experimental drug within 30 days of enrollment
13. Previously enrolled into this study, study D1447C00126 or study D1447C00127
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca, Quintiles staff or staff at the investigational site)

Exclusion criteria for entering the Randomized Treatment Phase
Any of the following is regarded as a criterion for exclusion from the study:
1. Hospitalization due to a mood event (manic, depressed or mixed) during the Open-label Treatment Phase
2. Electroconvulsive therapy (ECT) during the Open-label Treatment Phase
3. Attempt to commit suicide or homicide during the Open-label Treatment Phase
4. Substance or alcohol dependence (except dependence in full remission, and exce

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified