Optimal Treatment Duration with Olanzapine following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies
- Conditions
- to compare the efficacy in the prevention of relapse to manic, depressive, or mixed episodes in two groups of bipolar I patientsMedDRA version: 14.1Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2004-001308-11-ES
- Lead Sponsor
- illy.S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 0
[1]Male or female outpatients aged 18 years or older.
[2]Women enrolled in this trial who are of childbearing age must be using contraceptive methods that are appropriate in the opinion of the investigator.
[3]All patients must have the intellectual capacity necessary to understand and complete all the evaluations called for in the protocol.
[4]Each patient (or the person acknowledged as his/ her legal representative) must understand the nature of the study and sign an informed consent form before any study procedure is undertaken.
[5]Subjects must have a diagnosis of Bipolar I Disorder and must have recently experienced a manic or mixed episode according to DSM IV TR diagnostic criteria, whether or not said episode required hospital admission.
[6]Participants must be in syndromic remission, according to DSM IV TR criteria, as well as symptomatic [remission] of the manic or mixed episode at the time of enrolment in the study, with a total YMRS score of ? 12 and a HAMD score of ? 8 at Visit 1 and Visit 2.
[7]Olanzapine in mono or co-therapy must have been prescribed in all patients in order to achieve remission and treatment [with olanzapine] must have been maintained until the time of inclusion in the study.
[8]Patients must have suffered at least 2 manic or mixed episodes, including the current episode, in the course of the 3 years prior to inclusion in the study
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107
[9]Patients who have not experienced symptomatology of manic or mixed episodes in the month prior to admission into the study.
[10]Patients who at the time of inclusion or at other time during the study require treatment with antiepileptics or other substances with a potential mood-stabilizing effect (p. eg. New antiepileptics) other than lithium, valproic acid and/ or carbamacepine. (See section 5.7.)
[11]Personnel at the center of investigation who are directly related with the study or their immediate family. The term ?immediate family members? refers to spouse, parents, children, and siblings, both natural and adopted.
[12]Lilly personnel (that is, personnel with a permanent or temporary contract [with Lilly], or people designated and in charge of conducting this study). Members of the immediate families of Lilly personnel may participate in clinical trials sponsored by the company, but they may not do so at Lilly facilities. The term ?immediate family members? refers to spouse, parents, children, and siblings, both natural and adopted.
[13]Serious, unstable illness (including cardiac, hepatic, renal, respiratory, endocrine, neurological, hematological illnesses, morbid obesity and malnutrition) or anticipated hospitalization during the following six months, in the opinion of the clinical investigator.
[14]Treatment during the last 30 days with a medication that has not been approved by healthcare authorities at the time of enrolment into the study (Visit 1) or with a drug under study in another clinical trial.
[15]Clinical history of intolerance, allergic reaction, or serious adverse events with olanzapine.
[16]Pregnant female patients or nursing mothers.
[17]Confirmed diagnosis of schizophrenia or other psychotic disorder (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to medical illness or substances use, psychotic disorder not otherwise specified) according to DSM IV TR criteria.
[18]If the investigator believes there to be a risk of suicide.
[19]Patients who achieve remission with ETC (electroconvulsive therapy) as adjunct to psychopharmacological treatment.
[20]Substance use or abuse if it constitutes the primary diagnosis and the mood disorder is due to said use or abuse.
[21]Refractory hypo- or hyperthyroidism. Patients receiving replacement therapy must be asymptomatic on stable doses for at least two weeks before Visit 1.
6.A.3. Criterion for Admission into Study Period III
[22]Participants must be in syndromic and symptomatic remission of the manic, depressive, or mixed episode according to DSM IV TR criteria at the time of randomization, Visit 6, with a total score on the YMRS Scale of ? 12 and a score on the HAMD 21 of ? 8, scores that must have been maintained during Period II, allowing said scores to have been higher on a single occasion (under no circumstances at Visit 6) and that have not met criteria for symptomatic relapse (YMRS ? 15 and/ or HAMD ? 15).
6.A.4. Criterion for Admission into Study Period IV
[23]The patients that are enrolled in the study are those that suffer syndromic and/ or symptomatic relapse (YMRS ? 15 and/ or HAMD ? 15) from the treatment arm that discontinued treatment with olanzapine.
6.A.5. Exclusion Criterion for Study Period IV
[24]Patients requiring hospitalization following the discontinuation of treatment with olanzapine as of Study Period III.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method