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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.
DSM IV TR criteria will be used for manic and
depressive episodes in order to assess syndromic improvement.
To compare the efficacy of long-term treatments by means of longitudinal assessment using the
general subscale of the CGI BP M (Clinical Global Impression - Modified) and proceeding to
intra- and intergroup analyses.
To evaluate the safety of maintenance treatment
with olanzapine and other coadjuvant medication
in both groups of follow up. To collect data
regarding treatment-derived adverse events,
changes in vital signs, laboratory analyses, and to measure the severity of possible extrapyramidal symptoms.
The Simpson Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess the latter.
To determine the impact on resource utilization
the two treatment groups have. Direct costs derived
from hospital admissions, emergency room visits,
out-patient visits, home healthcare supports, as well as indirect costs derived from days out of work,
the patient's economic income, impact on the caregiver will also be quantified.
To assess the differences between groups
with respect to improvement in functioning and quality of life. The SF 36 Scale (the 36-Item Social Function Scale) will be applied.
To understand the degree of impact the illness provokes in relatives or caregivers
throughout the study. The self-report scale of
family burden (Escala de Carga Familiar - ECF) will be used for this purpose.

Full Information

First Posted
September 12, 2005
Last Updated
July 21, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00191997
Brief Title
Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed Episode
Official Title
Optimal Treatment Duration With Olanzapine Following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
The main objective of this study is to compare the efficacy in the prevention of relapse to manic, depressive, or
Title
mixed episodes in two groups of bipolar I patients
Title
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.
Title
The first group will receive olanzapine for a period of
Title
3 months following inclusion into the study; the second group will receive olanzapine for 12 months.
Title
Relapses will be evaluated in terms of the total YMRS
Title
(Young Mania Rating Scale) and HAMD-21 (the 21-item Hamilton Depression Rating Scale) scores.
Secondary Outcome Measure Information:
Title
The secondary objectives posed by this study are the following:
Title
To compare the efficacy of maintaining olanzapine for 3 months versus maintaining it for 12 months in
Title
the improvement of symptomatology in patients who had achieved remission. To this end, the reductions
Title
on the total YMRS score, YMRS specific non-psychotic
Title
item scores, HAMD 21 total score, the scores on the
Title
HAMD 21 specific mood-related items, the total and
Title
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.
Title
DSM IV TR criteria will be used for manic and
Title
depressive episodes in order to assess syndromic improvement.
Title
To compare the efficacy of long-term treatments by means of longitudinal assessment using the
Title
general subscale of the CGI BP M (Clinical Global Impression - Modified) and proceeding to
Title
intra- and intergroup analyses.
Title
To evaluate the safety of maintenance treatment
Title
with olanzapine and other coadjuvant medication
Title
in both groups of follow up. To collect data
Title
regarding treatment-derived adverse events,
Title
changes in vital signs, laboratory analyses, and to measure the severity of possible extrapyramidal symptoms.
Title
The Simpson Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess the latter.
Title
To determine the impact on resource utilization
Title
the two treatment groups have. Direct costs derived
Title
from hospital admissions, emergency room visits,
Title
out-patient visits, home healthcare supports, as well as indirect costs derived from days out of work,
Title
the patient's economic income, impact on the caregiver will also be quantified.
Title
To assess the differences between groups
Title
with respect to improvement in functioning and quality of life. The SF 36 Scale (the 36-Item Social Function Scale) will be applied.
Title
To understand the degree of impact the illness provokes in relatives or caregivers
Title
throughout the study. The self-report scale of
Title
family burden (Escala de Carga Familiar - ECF) will be used for this purpose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Barcelona
Country
Spain
Facility Name
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
City
Leon
Country
Spain
Facility Name
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
City
Lleida
Country
Spain
Facility Name
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
City
Madrid
Country
Spain
Facility Name
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
City
Murcia
Country
Spain
Facility Name
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
City
Ourense
Country
Spain
Facility Name
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
City
Salamanca
Country
Spain
Facility Name
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
City
Sevilla
Country
Spain
Facility Name
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
City
Tarrasa-Barcelona
Country
Spain
Facility Name
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
City
Vitoria
Country
Spain
Facility Name
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
City
Zamora
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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