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| ID | Type | Description | Link |
|---|---|---|---|
| F1D-XM-HGLW |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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. |
| 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 | León | 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 | Seville | 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-Gasteiz | 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 |
| D006571 | Heterocyclic Compounds |