Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186017
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2005-09-12
Brief Title:
Short Term Rescue Study of Olanzapine
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Double-Blind Placebo-Controlled Olanzapine Add-on Therapy in the Treatment of Acute Syndromal and Subsyndromal Exacerbations in Bipolar Disorders
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study In addition we will assess the effect of olanzapine on Young Mania Rating Scale YMRS Hamilton and Montgomery-Asberg Depression Rating Scales HDRS and MADRS and Hamilton Anxiety Rating Scales HARS in the above paradigms We will also assess the influence of presentation severity CGI-S and polarity mood elevation versus depression on olanzapine response Finally we will assess safety and tolerability of olanzapine in the above paradigms
We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in outpatients randomized double-blind flexibly dosed olanzapine added to prior treatment including no treatment will yield greater CGI-S improvement than placebo by the end of one week and that such improvement will persist over one week of open continuation treatment
We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in outpatients randomized double-blind flexibly dosed olanzapine added to prior treatment including no treatment will yield greater CGI-S improvement than placebo by the end of one week and that such improvement will persist over one week of open continuation treatment
Detailed Description:
Development and marketing of new therapies for bipolar disorders BD has typically entailed performing double-blind placebo-controlled trials in acute mania maintenance studies and more recently acute depression studies Such an approach addresses BD primarily in terms of episodes and has the strength of studying levels of pathology sufficiently high to permit detection of treatment effects and guiding clinicians when they encounter syndromal mood episodes However this approach has the important limitation of not addressing an important unmet clinical need namely the management of subsyndromal symptoms Indeed emerging data suggest that in BD subsyndromal symptoms compared to syndromal episodes are far more pervasive Also such an approach runs the risk of not paying sufficient attention to the disorder construct in a sense permitting preoccupation with syndromal episodes to carry more importance than the disorder
We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study In addition we will assess the effect of olanzapine on Young Mania Rating Scale YMRS Hamilton and Montgomery-Asberg Depression Rating Scales HDRS and MADRS and Hamilton Anxiety Rating Scales HARS in the above paradigms We will also assess the influence of presentation severity CGI-S and polarity mood elevation versus depression on olanzapine response Finally we will assess safety and tolerability of olanzapine in the above paradigms
We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study In addition we will assess the effect of olanzapine on Young Mania Rating Scale YMRS Hamilton and Montgomery-Asberg Depression Rating Scales HDRS and MADRS and Hamilton Anxiety Rating Scales HARS in the above paradigms We will also assess the influence of presentation severity CGI-S and polarity mood elevation versus depression on olanzapine response Finally we will assess safety and tolerability of olanzapine in the above paradigms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F1D-US-X279 | OTHER_GRANT | Eli Lilly | None |