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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Recruitment Status : Withdrawn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 : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Paliperidone 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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01584466


Locations
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United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, College Park

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Responsible Party: MPRC, Heidi Wehring, PharmD, BCPP, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01584466     History of Changes
Other Study ID Numbers: HP-00052194
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by MPRC, University of Maryland, College Park:
Schizophrenia
Substance Abuse
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents