SchizophreniaNCT01584466
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
A study testing Paliperidone in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
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
- Being tested
- Paliperidone
- Keywords
- Schizophrenia, Substance Abuse
- Medical subject headings
- Schizophrenia, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliperidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone | Experimental | Not described Receives: Drug: Paliperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584466
- Sponsor's protocol ID
- HP-00052194
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2012
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT01584466
- Acronym / sponsor ID
- HP-00052194
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone | Experimental | Drug: Paliperidone |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaliperidoneThe 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. | Drug | Paliperidone |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paliperidone in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.