Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
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|ClinicalTrials.gov Identifier: NCT01584466|
Recruitment Status : Withdrawn
First Posted : April 25, 2012
Last Update Posted : January 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|