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Completed

NCT Number: NCT00191997

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

Primary outcomes

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

  2. mixed episodes in two groups of bipolar I patients

  3. 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.

  4. The first group will receive olanzapine for a period of

  5. 3 months following inclusion into the study; the second group will receive olanzapine for 12 months.

  6. Relapses will be evaluated in terms of the total YMRS

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

Secondary outcomes

  1. The secondary objectives posed by this study are the following:

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

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

  4. on the total YMRS score, YMRS specific non-psychotic

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

  6. HAMD 21 specific mood-related items, the total and

  7. 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.

  8. DSM IV TR criteria will be used for manic and

  9. depressive episodes in order to assess syndromic improvement.

  10. To compare the efficacy of long-term treatments by means of longitudinal assessment using the

  11. general subscale of the CGI BP M (Clinical Global Impression - Modified) and proceeding to

  12. intra- and intergroup analyses.

  13. To evaluate the safety of maintenance treatment

  14. with olanzapine and other coadjuvant medication

  15. in both groups of follow up. To collect data

  16. regarding treatment-derived adverse events,

  17. changes in vital signs, laboratory analyses, and to measure the severity of possible extrapyramidal symptoms.

  18. The Simpson Angus Scale, Barnes Akathisia Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess the latter.

  19. To determine the impact on resource utilization

  20. the two treatment groups have. Direct costs derived

  21. from hospital admissions, emergency room visits,

  22. out-patient visits, home healthcare supports, as well as indirect costs derived from days out of work,

  23. the patient's economic income, impact on the caregiver will also be quantified.

  24. To assess the differences between groups

  25. with respect to improvement in functioning and quality of life. The SF 36 Scale (the 36-Item Social Function Scale) will be applied.

  26. To understand the degree of impact the illness provokes in relatives or caregivers

  27. throughout the study. The self-report scale of

  28. family burden (Escala de Carga Familiar - ECF) will be used for this purpose.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jul 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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