Bipolar I Disorder
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients able to give informed consent, and/or consent obtained from a legally acceptable representative (as required by IRB/IEC) prior to the initiation of any protocol required procedures; 2) Patients meeting DSM-IV-TR criteria for Bipolar I Disorder, currently experiencing a manic or mixed episode with or without psychotic features, as confirmed by the SCID; Rapid cyclers with 12 and/or a MADRS total score > 12) in the intervening interval; b) Y-MRS and a MADRS total score of = 12 at the final Phase 2 Visit. 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: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. 2) WOCBP using a prohibited contraceptive method. 3) Women who are pregnant or breastfeeding. 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Patients presenting with a current DSM-IV-TR diagnosis of delirium, dementia, amnestic or other cognitive disorders, or a psychotic disorder. Also, patients with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder; 6) Patients with a current Axis I (DSM-IV-TR) diagnosis of bipolar II disorder, rapid cyclers experiencing seven or more mood episodes (manic, depressive, or mixed) within the past year, bipolar disorder NOS, or any other primary psychiatric disorder other than Bipolar I Disorder; 7) Patients experiencing their first manic episode; 8) Patients with a current manic or mixed episode with a duration of > 2 years; 9) Patients considered treatment refractory to treatment for manic symptoms. In addition, patients with a history of unresponsiveness to clozapine must be discussed with the CRO Medical Monitor prior to initiating study medication; 10) Patients with a significant risk of committing suicide; 11) Patients who currently meet DSM-IV-TR criteria for substance abuse or substance dependence; 12) Patients with thyroid pathology, unless condition has been stabilized with medications for at least the past three months. In addition, patients with thyroid conditions will not be allowed treatment with lithium; 13) Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial; 14) Patients with epilepsy or a history of seizures (except for childhood febrile seizures, post traumatic, alcohol withdrawal, etc.); 15) Patients with a CPK = 550 U/L must be approved by the sponsor prior to randomization; 16) Patients with a positive drug screen for cocaine; 17) The following laboratory tests results, vitals signs, and ECG findings are exclusionary: a) Platelets = 75,000/mm3 b) Hemoglobin = 9g/dL c) Neutrophils, Absolute = 1000/ mm3 d) SGOT (AST) > 3x Upper Limit of Normal e) SGPT (ALT) > 3x Upper Limit of Normal f) Creatinine = 2 mg/dL g) Patients may be retested during the screening period (Phase 1) at the investigator’s discretion. Upon retest, if results do not meet the exclusion criteria listed above, the patient may continue onto Phase 2; h) Diastolic blood pressure > 105 mmHg i) QTc > 475 msec In addition, patients should be excluded if they have any other abnormal laboratory test result, vital sign result, or ECG finding that in the investigator's judgment is medically significant, in that it would impact the safety of the patient or the interpretation of the study results (see Protocol Appendices 3, 4, and 5); 18) Patients who are known to be allergic, intolerant, or unresponsive to previous aripiprazole treatment; 19) Hypersensitivity to antipsychotic agents; 20) Patients allergic, intolerant, hypersensitive or refractory to both lithium and valproate; 21) Patients with a history of neuroleptic malignant syndrome from antipsychotic agents; 22) Patients likely to require prohibited concomitant therapy, (see Protocol Section 6.4); 23) Patients who have participated in a clinical trial with an investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of aripiprazole in combination with lithium or valproate, compared with placebo in combination with lithium or valproate, as long-term maintenance therapy for patients with Bipolar I Disorder, manic or mixed, with or without psychotic features, demonstrating maintenance of stability for a minimum of 12 weeks when treated with aripiprazole in combination with lithium or valproate, as measured by the time to relapse.;Secondary Objective: To evaluate the safety and tolerability of aripiprazole in combination with lithium or valproate as long-term maintenance therapy in this same patient population.;Primary end point(s): The primary efficacy outcome measure will be the time from randomization to relapse to any mood episode. Secondary Outcome Measures include mean change from baseline (end of Phase 2) to endpoint (Week 52 LOCF) in the following scales: • CGI-BP Severity of Illness Score (mania) | — |
Countries
Czech Republic
Outcome results
None listed