Subjects Had Unipolar, Non-psychotic Major Depression Clinical Trial
Official title:
A Double Blind Pilot Trial to Evaluate Efficacy Trends and Safety of Risperidone and Olanzapine as add-on Therapy to Serotonin Type Antidepressants in Subjects With Treatment Resistant Depression (TRD)
Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar depression. Some data support the use of both Risperidone and Olanzapine, but there are no direct comparisons of their relative efficacy and tolerability in treatment resistant depression. The current study was designed as a pilot study to examine efficacy and tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor (SSRI) in depression.
Overview of Study Design
This is a Canadian, multicentre, double blind, comparator trial in 42 patients with TRD. TRD
is defined as the failure to respond adequately to two successive courses of different
antidepressants at an adequate dose (at least fluoxetine 20 mg, citalopram 20 mg, paroxetine
20 mg, sertraline 100 mg, fluvoxamine 150 mg, venlafaxine 225 mg)) for at least 4 weeks. All
subjects, at entry to the study will be currently not responding to treatment of at least 4
weeks duration of a serotonin re-uptake inhibitor (SSRI) or a selective nor-epinephrine and
serotonin re-uptake inhibitor (SNRI). Non-response is defined as a score of 3 ("minimal
improvement") or worse on the Clinical global Impression of Improvement .
The objective is to assess the appropriateness of the trial design and to determine sample
size requirements for future controlled trials. In addition the efficacy and safety of oral
doses of risperidone (.5-3 mg/day) and olanzapine (2.5-15 mg.day) as add-on therapy to any
SSRI or SNRI in treatment resistant depression will be evaluated. Subjects meeting the
screening criteria will enter a 6-week trial with risperidone or olanzapine added on to the
current SSRI or SNRI therapy.
A medical/ psychiatric history, HAM-D-29 (only the first 17 items will be used for outcome),
MADRS and HAM-A will be obtained at screening. At subsequent visits HAM-D, HAM-A, and MADRS
will be performed and adverse events (spontaneous and using the CASES checklist) and
concomitant medications will be collected.
Recruitment:
Subjects will drawn from two sources:
1. Outpatients currently attending the clinic at the sites. These subjects will already be
in treatment or may have been referred from the local communities of the clinics
involved in this study for consultation. Should these subjects drop out or once they
have completed the study they will receive the treatment as usual at each site.
2. Advertisements. Advertisements will be placed in local media (radio, television,
newspaper) identifying the nature of the study and providing a contact number. These
advertisements will be approved by the local IRB's prior to posting.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment