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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01584466
• Other study ID #: HP-00052194
• Status: Withdrawn
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2014

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint	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.	7 months