CompletedPhase 4

Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed Episode

Spain180 participantsStarted 2004-10

Plain-language summary

This is a randomized, parallel, open-label study of patients who have responded to treatment in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the time of enrollment into the study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Outpatients, male or female, at least 18 years old * Patient or legal representative must understand the study and sign an informed consent document before any study procedure * Must have a diagnosis of Bipolar Disorder type I and have a recent manic or mixed episode, with or without hospitalization, according to DSM-IV-TR criteria. * Patients must be in syndromic and symptomatic remission, following DSM-IV-IR criteria, for the manic or mixed episode, at the time of study entry, with a total score for YMRS less than or equal to 12 and total store for HAMD less than or equal to 8 at visit 1 and 2. * Remission must have been achieved taking olanzapine in mono or co-therapy, and it must have been maintained until study entry. * Patients must have had, at least, 2 manic or mixed episodes within 3 years of the study entry, taking into account the current one. Exclusion Criteria: * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry, or with a study drug in other clinical trial * Patients without symptoms or manic or mixed episode within one month of study entry. * Confirmed diagnoses of Schizophrenia or other psychotic disorders (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, substance-induced or medical condition psychotic disorder, psychotic disorder NOS),following DSM-IV-TR criter…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or

mixed episodes in two groups of bipolar I patients

who responded to open-label treatment with olanzapine in mono or co-therapy and who are in symptomatic and syndromic remission at the time of entering the study.

The first group will receive olanzapine for a period of

3 months following inclusion into the study; the second group will receive olanzapine for 12 months.

Relapses will be evaluated in terms of the total YMRS

(Young Mania Rating Scale) and HAMD-21 (the 21-item Hamilton Depression Rating Scale) scores.

Trial details

NCT IDNCT00191997

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Bipolar Disorder trials