Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 3/1/2014 |
| Start Date: | January 2014 |
| End Date: | March 2017 |
| Contact: | Ann Kearns, B.S |
| Email: | akearns@mprc.umaryland.edu |
| Phone: | 410-402-6854 |
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
