None listed
Conditions
Interventions
Group Aripiprazol Type of group
Aripiprazole will be started on Day 1 with 15 mg daily, with the option of increasing to 30 mg daily on day 4 or later depending on the clinical response
Group name:Group Placebo Type of group
Daily administration of placebo will be initiated during weeks 1, 2 or 3. Subsequently, they will start receiving aripiprazole blindly until week 12. Aripiprazole will start with 15 mg or 30 mg, with dose adjustments according to clinical response.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who can provide informed consent and / or consent obtained from a legally acceptable representative 2) Patients with Bipolar I Disorder associated with manic or mixed episode 3) Patients who have a history of at least 1 manic episode or mixed 4) Patients with a Total Score in the Y-MRS> 20 in the selection and at the end of Phase 1 (baseline) 5) Patients with a Total Score in MADRS 18 years.
Exclusion criteria
Exclusion criteria: 1) Women of childbearing age who do not wish or can not use an acceptable method to avoid pregnancy during the entire study. 2) Women of childbearing age who use a prohibited method of contraception 3) Women who are pregnant or breastfeeding 4) Women with positive results in the pregnancy test. 5) Patients who present and / or have a history that is compatible with other psychiatric illnesses 6) Patients with current diagnosis of Bipolar II Disorder 7) Patients who experience their first manic or mixed episode. 8) Patients considered refractory for the treatment of manic symptoms. 9) Patients who have been hospitalized for> 3 weeks for the current manic or mixed episode. 10) Patients with significant risk of committing suicide 11) Patients diagnosed with substance abuse within the last 3 months. 12) Patients with thyroid disease. 13) Patients who have a history or evidence of a medical condition that would expose them to the undue risk of a significant adverse event 14) Patients with epilepsy or a history of seizures 15) Patients who test positive in the pharmacological analysis for cocaine. 16) Patients with significant abnormal results in laboratory tests, vital signs or ECG findings 17) Patients who have a CPK> 550 U / L must be approved before randomization. 18) Patients allergic, intolerant or that did not respond to previous treatments for mania in which haloperidol was used. 19) Patients with a history of hypersensitivity to antipsychotic agents. 20) Patients with a history of neuroleptic malignant syndrome 21) Patients who are using mood stabilizers 22) Patients who have received antidepressants within the previous two weeks 23) Patients likely to require concomitant therapy prohibited during the study 24) The recent treatment of his most recent manic or mixed acute episode with a long-acting antipsychotic. 25) Patients who have participated in a clinical trial with an agent in investigation within the last month or that has ever participated in a clinical trial with aripiprazole 26) Patients who probably need intensive individual psychotherapy 27) Management with electroconvulsive therapy in the last 3 months 28) In this study prisoners or individuals who are forcibly detained should not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Average change from the baseline to Week 3 (LOCF) on the Total Score of the Y-MRS. Measure:Efficacy of therapy with Aripiprazole. Timepoints:Before treatment (basal) and in week 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Application and evaluation of the scales: Y-MRS, MADRS, CGI-BP, PANSS. Discontinuation time: Investigator evaluation. Measure:Secondary efficacy measures in week 12: Percentage of senders (Total score of the Y-MRS 50% in the Total Score of the Y-MRS). Percentage of patients that achieve response or remission in the Y-MRS. Emerging depression index (MADRS Total score ≥ 18 with an increase from the baseline ≥ 4 in either of two consecutive evaluations or the last observation). Time to discontinuation due to lack of efficacy. Time until the discontinuation of the study for some reason. Average change from the baseline in the Severity Score of the Disease in the CGI-BP. Average Change Score from the Previous Phase in the CGI-BP. Change response index from the previous phase in the CGI-BP. Average change from the baseline in the Total PANSS, Positive PANSS and PANSS Negative Scores. Average change from the baseline in the PANSS Hostility Subscale Scores and the PANSS Cognitive Sub-Scale. Average change from the baseline in the MADRS Total Score. Time to symptomatic remission of mania (Y-MRS ≤12). Time to symptomatic remission of mania and depression (Y-MRS ≤ 12 and Total Score of MADRS ≤ 8). Timepoints:Y-MRS, MADRS, CGI-BP: Days 1, 2, 4, week 1, day 10, weeks 2, 3, 4, 5, 6, 8 and finally week 12. PANSS: Day 1 and week 3 Researcher evaluation: When the event is presented. ; Outcome name:Application and evaluation of the scales: Y-MRS, CGI-BP. Measure:Secondary efficacy measures of week 12 for patients who responded in week 3 (improvement ≥ 50% from the baseline in the total score of the Y-MRS): Mean change from the baseline in the Total Score of the Y-MRS. Percentage of relapsers (Y-MRS ≤ 12). Response rate (improvement> 50% from the baseline in the Total Score of the Y-MRS). Change response rate from the previous phase (% of patients rated as much better or much better from the baseline) | — |
Countries
Estonia, Hungary, Italy, Peru, Spain
Outcome results
None listed