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

Not Applicable

Withdrawn

• Conditions: Schizophrenia
• Interventions: Drug: Paliperidone

• Registration Number: NCT01584466
• Lead Sponsor: University of Maryland, Baltimore

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 available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-25
• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paliperidone	Paliperidone	-

Primary Outcome Measures

Name	Time	Method
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint	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.

Trial Locations

Locations (1)

Maryland Psychiatric Research Center; 🇺🇸 Catonsville, Maryland, United States