Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT02413918
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2015-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Iloperidone in Mixed States of Bipolar Disorder
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Open Label Study of Iloperidone (IL) as Adjunctive Treatment in Mixed States (MS) of Bipolar Disorder (BD)
Status:
COMPLETED
Status Verified Date:
2017-05
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:
1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS
2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS
Detailed Description:
This is a prospective 20-week, open-label study of iloperidone added to ongoing treatment regimen with mood stabilizers (Li or DIV or LAM or any combination of these) in the acute and maintenance treatment of MS- Total number of subjects: 40.
Severity of the illness and psychopathological features will be measured by the following rating scales: YMRS, MADRS, CGI-S and GAS, and the BISS .
The study will monitor the safety and tolerability of the combination iloperidone plus mood stabilizers.
Efficacy Measures: Primary efficacy measures include 1) Mixed effects repeat measure of change from baseline in BISS total score and, secondarily, manic and depression subscale scores.
Secondary Efficacy Measures: 1) response defined as 50% reduction in YMRS and MADRS and 2) Time to intervention or discontinuation for any mood episode.
Iloperidone will be initiated at 2 mg at hs on day 1 with increase to 4mg at hs on day 2, 8 mg at hs on day 3. All patients will have iloperidone titrated to receive a dosage of at least 12 mg a day. Dosages can be titrated up to 24 mg a day based on tolerability and clinical indication. Dosage of iloperidone can be reduced to 6 mg a day if patients develop side effects necessitating a reduction in the dosage
Severity of the illness and psychopathological features will be measured by the following rating scales: YMRS, MADRS, CGI-S and GAS, and the BISS .
The study will monitor the safety and tolerability of the combination iloperidone plus mood stabilizers.
Efficacy Measures: Primary efficacy measures include 1) Mixed effects repeat measure of change from baseline in BISS total score and, secondarily, manic and depression subscale scores.
Secondary Efficacy Measures: 1) response defined as 50% reduction in YMRS and MADRS and 2) Time to intervention or discontinuation for any mood episode.
Iloperidone will be initiated at 2 mg at hs on day 1 with increase to 4mg at hs on day 2, 8 mg at hs on day 3. All patients will have iloperidone titrated to receive a dosage of at least 12 mg a day. Dosages can be titrated up to 24 mg a day based on tolerability and clinical indication. Dosage of iloperidone can be reduced to 6 mg a day if patients develop side effects necessitating a reduction in the dosage
Study Oversight
Has Oversight DMC:
True
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?: