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Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths (PRISMA-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT01788774
First received: February 5, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Risperidone ISM 50 mg
Drug: Risperidone ISM 75 mg
Drug: Risperidone ISM 100 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • Area under the curve [ Time Frame: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame ]

Enrollment: 36
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Risperidone ISM 50mg
Three different single doses will be evaluated
Drug: Risperidone ISM 50 mg
Risperidone ISM 75mg
Three different single doses will be evaluated
Drug: Risperidone ISM 75 mg
Risperidone ISM 100mg
Three different single doses will be evaluated
Drug: Risperidone ISM 100 mg

Detailed Description:

This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.

Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:

Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of providing informed consent.
  • Male or female aged ≥ 18 years to < 65 years
  • Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
  • Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
  • Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
  • If a sexually active female of childbearing potential, using a medically accepted contraceptive method.

Exclusion Criteria:

  • Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
  • If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
  • History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
  • Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
  • In the investigator's opinion, at imminent risk of committing self-harm
  • Use of depot antipsychotics within the last three months
  • Receipt of any investigational drugs within the last three months
  • Current participation in any other clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788774

Locations
Croatia
TBD, Croatia
Russian Federation
TBD, Russian Federation
South Africa
TBD, South Africa
Spain
TBD, Spain
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
  More Information

Responsible Party: Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier: NCT01788774     History of Changes
Other Study ID Numbers: ROV-RISP-2011-01
2012-003303-35 ( EudraCT Number )
Study First Received: February 5, 2013
Last Updated: October 6, 2014

Keywords provided by Rovi Pharmaceuticals Laboratories:
Pharmacokinetics
Safety
Risperidone ISM®
Intramuscular
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 24, 2017