| City: |
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West Allis |
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State:
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WI |
| Zip Code: |
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53227 |
| Conditions: |
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Treatment Resistant Depression |
| Purpose: |
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The purpose of this study is to determine whether olanzapine and fluoxetine combination
(OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant
Depression stable, determine if OFC is safe when used to treat patients with Treatment
Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and
fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression
when treated for a long time ( up to 47 weeks) and to assess the quality of life during
treatment.
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| Study summary: |
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This is a multicenter, randomized, double-blind, active comparator-controlled, parallel
study of patients with Treatment Resistant Depression (TRD), comparing the efficacy and
safety of olanzapine and fluoxetine Combination (OFC) versus fluoxetine in relapse
prevention of stabilized patients with TRD. The study will consist of 4 phases: a screening
phase; a 6- to 8-week open-label acute treatment phase; a 10- to 12-week open-label
stabilization phase; and a 27- to 29-week double-blind relapse prevention treatment phase.
Patients who demonstrate response to open-label OFC during the acute treatment phase will
continue into the stabilization phase. Patients who remain stable while receiving open-label
OFC during this phase will be randomized to receive either OFC or fluoxetine during the
double-blind relapse prevention phase. Investigators and patients will be blinded to the
precise duration of the stabilization period, the definition of remission, and the criteria
for entry into the relapse prevention phase; this information is described in a supplement
given to Ethical Review Boards (ERBs) and regulatory authorities. |
| Criteria: |
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Inclusion Criteria:
- Have single or recurrent unipolar (Major Depressive Disorder) MDD, without psychotic
features by DSMIV- TR clinical assessment, confirmed by the structured clinician
Interview for DSM-IV Axis 1 disorders.
- If female and of childbearing potential, test negative for pregnancy and agree to
abstain from sexual activity or use a medically accepted means of contraception
during the study. Use of any oral or injectable contraception must be initiated prior
to receiving treatment.
- Have 17-item (Hamilton Depression) HAM-D score greater than or equal to 18 at
screening and the day treatment is due to be received for the first time.
- Have treatment-resistant depression, as defined by having demonstrated failure to
achieve satisfactory antidepressant response to adequate separate treatment courses
of at least 2 different antidepressants within the current episode of MDD.
Exclusion Criteria:
- Have a diagnosis of Parkinson's disease or related disorders.
- Have a current or lifetime diagnosis of any of the following according to DSM-IV
criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder,
Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Bipolar Disorder I
or II, Delirium of any type, Dementia of any type, Amnestic Disorder, any
Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical
Condition.
- Have current diagnosis of post-partum depression, MDD with atypical features, or MDD
with a seasonal pattern as defined in the DSM-IV.
- Have paranoid, schizoid, schizotypal, antisocial, and borderline personality
disorders (Axis II) as a comorbid or primary diagnosis, based on DSM-IV criteria.
- Have had psychotic symptoms within 1 month prior to Screening or demonstrate
psychotic features at screening and on the day treatment is due to be assigned for
the first time as determined by the investigator.
- Have DSM-IV substance dependence/abuse or not willing to avoid use of the substance
(not including dependence on nicotine or caffeine), as defined by the SCID-I, within
the past 30 days.
- Are actively suicidal in the judgment of the investigator.
- Have had one or more seizures without a clear and resolved etiology.
- Have leukopenia or history of leukopenia without a clear and resolved etiology, or
known history of agranulocytosis during the patient's lifetime.
- Have ALT/SGPT values greater than or equal to 2 times the upper limit of normal (ULN)
of the performing laboratory or AST/SGOT values greater than or equal to 2 times the
ULN or total bilirubin values greater than or equal to 1.5 times the ULN at any time
during screening.
- Have acute, serious, or unstable medical conditions.
- Have any illness such that death is anticipated within 1 year or intensive care unit
hospitalization for the illness is anticipated within 6 months.
- Have elevated prolactin levels at screening.
- Have QTc Bazett's greater than 450 milliseconds (male) or greater than 470
milliseconds (female) at screening and when treatment is due to be received for the
first time.
- Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS)
treatment within the current episode; have a history of failure to adequate treatment
courses of ECT or VNS; or will require ECT or VNS at any time during study
participation.
- If receiving psychotherapy, light therapy, or both, are anticipated to require
changes in frequency/intensity of treatment regimen or to cease treatment regimen
over the duration of the study. Patients who are not receiving any of these
therapies upon study entry may not begin any of these therapies during screening, or
during any treatment phases of the study.
- Have received previous treatment with clozapine.
- Have used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or
are expected to need MAOI treatment at any time during this study through 5 weeks
after the patient discontinues from the study. |
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| Study is available at: |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
West Allis, WI 53227
United States
Primary Contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)
Phone: 1-317-615-4559 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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