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

Bipolar Disorder Clinical Trial

Official title:

Optimal Treatment Duration With Olanzapine Following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191997
• Other study ID #: 8834
• Secondary ID: F1D-XM-HGLW
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 21, 2006
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

Outcome

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