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Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01584466
Recruitment Status : Withdrawn
First Posted : April 25, 2012
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE April 25, 2012
Last Update Posted Date November 4, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint [ Time Frame: 7 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01584466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Official Title  ICMJE Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Paliperidone

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.

Study Arms  ICMJE Experimental: Paliperidone
Intervention: Drug: Paliperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
40
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01584466
Other Study ID Numbers  ICMJE HP-00052194
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MPRC, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP