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Iloperidone in Mixed States of Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02413918
Recruitment Status : Completed
First Posted : April 10, 2015
Results First Posted : November 6, 2017
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Vanda Pharmaceuticals
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: iloperidone Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of Iloperidone (IL) as Adjunctive Treatment in Mixed States (MS) of Bipolar Disorder (BD)
Study Start Date : April 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Iloperidone

Arm Intervention/treatment
Experimental: Open Label iloperidone
open label iloperidone (oral tablet, 6mg-24mg, QD, 20 weeks) as adjunct to current lithium, divalproex, or lamotrigine.
Drug: iloperidone
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.
Other Name: Fanapt




Primary Outcome Measures :
  1. Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores [ Time Frame: Baseline and 20 weeks ]

    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

    1. Slight
    2. Mild
    3. Moderate
    4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413918


Locations
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United States, Texas
UT Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Novartis Pharmaceuticals
Vanda Pharmaceuticals
Investigators
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Principal Investigator: Charles Bowden, MD UT Health Science Center San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02413918     History of Changes
Other Study ID Numbers: HSC20120137
First Posted: April 10, 2015    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: February 8, 2018
Last Verified: May 2017

Keywords provided by The University of Texas Health Science Center at San Antonio:
mixed episode

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Iloperidone
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs