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

NCT ID: NCT01584466

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone

Group Type: EXPERIMENTAL

Paliperidone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

MPRC

Heidi Wehring, PharmD, BCPP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Other Identifiers

HP-00052194

Identifier Type: -

Identifier Source: org_study_id