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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01584466

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Paliperidone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maryland Psychiatric Research Center	Catonsville	Maryland	United States	21228

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MPRC, Heidi Wehring, PharmD, BCPP, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT01584466

Other Study ID Numbers:

HP-00052194

First Posted:

Apr 25, 2012

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Keywords provided by MPRC, Heidi Wehring, PharmD, BCPP, University of Maryland, Baltimore

Schizophrenia

Substance Abuse

Additional relevant MeSH terms:

Schizophrenia

Paliperidone Palmitate

Study Results

No Results Posted as of Mar 17, 2022