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Iloperidone in Mixed States of Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
iloperidone
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring mixed episode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female;
  2. Age 18 years and older

  3. Patients on:

    • Li at a stable dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 0.5 mEq/l OR
    • DIV dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 45 ug/ml OR
    • LAM (dosage/day ≥100mg) at a stable dose for 2 weeks or longer OR
    • Any combination 3a, 3b, or 3c
  4. Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
  5. Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
  6. Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
  7. Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14

Exclusion Criteria:

  1. Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic sub-type that requires hospitalization, drug induced mania or AIDS induced mania
  2. Women with a positive pregnancy test or who are lactating
  3. Women of child-bearing potential who are not practicing a clinically accepted method of contraception
  4. Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
  5. Patients whose clinical status requires inpatient or day hospital treatment
  6. History of severe side effects associated with therapeutic doses of Li, DIV, LAM
  7. Alcohol or drug dependent at time of enrollment
  8. Suicidal at time of enrollment.
  9. Current or previous exposure to iloperidone
  10. Patients taking medication that cause QTC prolongation
  11. Patients with serious cardiac disease

Sites / Locations

  • UT Health Science Center San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label iloperidone

Arm Description

open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.

Outcomes

Primary Outcome Measures

Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores
The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows: 0 Not at all Slight Mild Moderate Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period. For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression. For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2015
Last Updated
January 12, 2018
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Novartis Pharmaceuticals, Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02413918
Brief Title
Iloperidone in Mixed States of Bipolar Disorder
Official Title
Open Label Study of Iloperidone (IL) as Adjunctive Treatment in Mixed States (MS) of Bipolar Disorder (BD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Novartis Pharmaceuticals, Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
mixed episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label iloperidone
Arm Type
Experimental
Arm Description
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
Intervention Type
Drug
Intervention Name(s)
iloperidone
Other Intervention Name(s)
Fanapt
Intervention Description
Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
Primary Outcome Measure Information:
Title
Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores
Description
The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows: 0 Not at all Slight Mild Moderate Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period. For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression. For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20.
Time Frame
Baseline and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female; Age 18 years and older Patients on: Li at a stable dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 0.5 mEq/l OR DIV dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 45 ug/ml OR LAM (dosage/day ≥100mg) at a stable dose for 2 weeks or longer OR Any combination 3a, 3b, or 3c Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7 Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ; Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 Exclusion Criteria: Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic sub-type that requires hospitalization, drug induced mania or AIDS induced mania Women with a positive pregnancy test or who are lactating Women of child-bearing potential who are not practicing a clinically accepted method of contraception Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases. Patients whose clinical status requires inpatient or day hospital treatment History of severe side effects associated with therapeutic doses of Li, DIV, LAM Alcohol or drug dependent at time of enrollment Suicidal at time of enrollment. Current or previous exposure to iloperidone Patients taking medication that cause QTC prolongation Patients with serious cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bowden, MD
Organizational Affiliation
UT Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Iloperidone in Mixed States of Bipolar Disorder

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