Back to resultsLong Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paliperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Substance Abuse
Eligibility Criteria
Inclusion Criteria:
- Be between ages 18 and 64
- Either gender
- Any race
- Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
- Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
- Agree to take or use birth control during the study.
Exclusion Criteria:
- Previous lack of response or serious adverse event to risperidone or paliperidone.
- Currently on a long acting injectable antipsychotic.
- A score of less than 10 on the Evaluation to Sign Consent (ESC).
- Medical illnesses, which may compromise safe study participation.
- Pregnant and lactating females.
- QTc interval > 450 milliseconds males or > 470 milliseconds in females
- Currently on acamprosate, naltrexone and disulfiram.
Sites / Locations
- Maryland Psychiatric Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone
Arm Description
Outcomes
Primary Outcome Measures
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint during six months of treatment. Improvement in psychotic symptoms will be measured by decrease in the Brief Psychiatric Rating Scale (BPRS) psychosis score. Improvement in negative symptoms will be measured by decrease in the Scale for the Assessment of Negative Symptoms (SANS) total score. Improvement in depressive symptoms will be measured by decrease in Calgary Depression Scale (CDS) total score.
Secondary Outcome Measures
Full Information
NCT ID
NCT01584466
First Posted
March 20, 2012
Last Updated
March 1, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01584466
Brief Title
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Official Title
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and nonadherence, which is one of the most problematic issues. People with schizophrenia and substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do not use alcohol and illicit drugs. The investigators propose that this new marketed injectable antipsychotic with many benefits over other available long acting injectable agents would be beneficial in the dually diagnosed population and may represent a specific schizophrenia subpopulation where long acting agents may be considered an important therapeutic option.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone
Intervention Description
The starting regimen will be a 'loading dose' strategy whereby the first injection will be 234 mg given on treatment week 0,day 1 and 156 mg (2nd injection) will be given 1 week later (days 5-9). Both are recommended to be administered in the deltoid muscle (PI 2011). Following the second dose, monthly maintenance doses will be administered in either the deltoid or gluteal muscle (PI 2011). The monthly (± 7 days) maintenance dose will be 117 mg.
Discontinuation of oral antipsychotics is recommended after the subjects receive paliperidone palmitate injection on Week 0/day 1. Continued oral antipsychotics may be used only if necessary.
Primary Outcome Measure Information:
Title
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint
Description
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint during six months of treatment. Improvement in psychotic symptoms will be measured by decrease in the Brief Psychiatric Rating Scale (BPRS) psychosis score. Improvement in negative symptoms will be measured by decrease in the Scale for the Assessment of Negative Symptoms (SANS) total score. Improvement in depressive symptoms will be measured by decrease in Calgary Depression Scale (CDS) total score.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be between ages 18 and 64
Either gender
Any race
Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
Agree to take or use birth control during the study.
Exclusion Criteria:
Previous lack of response or serious adverse event to risperidone or paliperidone.
Currently on a long acting injectable antipsychotic.
A score of less than 10 on the Evaluation to Sign Consent (ESC).
Medical illnesses, which may compromise safe study participation.
Pregnant and lactating females.
QTc interval > 450 milliseconds males or > 470 milliseconds in females
Currently on acamprosate, naltrexone and disulfiram.
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
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