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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191997
First received: September 12, 2005
Last updated: July 21, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Treatment Duration With Olanzapine Following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment: 180
Study Start Date: October 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191997

Locations
Spain
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
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
Leon, Spain
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
Lleida, Spain
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
Madrid, Spain
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
Murcia, Spain
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
Ourense, Spain
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
Salamanca, Spain
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
Sevilla, Spain
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
Tarrasa-Barcelona, Spain
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
Vitoria, Spain
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
Zamora, Spain
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00191997     History of Changes
Other Study ID Numbers: 8834, F1D-XM-HGLW
Study First Received: September 12, 2005
Last Updated: July 21, 2006
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014