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

Phase 4CompletedNCT00191997

Eli Lilly and Company180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Bipolar Disorder

Interventions

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 criteria. * Patients that have achieved remission with ECT (electro convulsive therapy) in addition to psychopharmacological treatment * Drug dependence or abuse, if it is a primary diagnose and the mood disorder is due to his administration * Patients that at the time of study entry or at any other time of study, need treatment with antiepileptics or other substances with potential effect as mood stabilizers (i,e new antiepileptics different to Lithium, Valproic Acid and/or Carbamazepine

Locations (11)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

The secondary objectives posed by this study are the following:

To compare the efficacy of maintaining olanzapine for 3 months versus maintaining it for 12 months in

the improvement of symptomatology in patients who had achieved remission. To this end, the reductions

on the total YMRS score, YMRS specific non-psychotic

item scores, HAMD 21 total score, the scores on the

HAMD 21 specific mood-related items, the total and

positive scores on the BPRS (Brief Psychiatric Rating Scale), and the CGI BP S(Clinical Global Impression of Severity) with respect to baseline will be evaluated.

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Barcelona, Spain

León, Spain

Lleida, Spain

Madrid, Spain

Murcia, Spain

Ourense, Spain

Salamanca, Spain

Seville, Spain

Tarrasa-Barcelona, Spain

Vitoria-Gasteiz, Spain

...and 1 more locations