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Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia (PRISMA-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT02086786
First received: February 10, 2014
Last updated: May 4, 2015
Last verified: May 2015
  Purpose
To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Condition Intervention Phase
Schizophrenia
Drug: Risperidone ISM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Two-arm, Parallel-design, Repeat-dose Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Four Intramuscular Injections of Risperidone ISM® 75 mg, at 28 Day Intervals in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Trough Plasma Concentration (Cmin) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Active Moiety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]

Secondary Outcome Measures:
  • Peak Plasma Concentration (Cmax) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Trough Plasma Concentration (Cmin) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Occurrence, nature, onset time, duration, intensity, action taken, outcome and relationship to study drug of AEs as a Measure of Safety [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Risperidone and 9OH-Risperidone Moieties [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]
  • Area Under the Concentration-time Curve for To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable ISM formulation [ Time Frame: Pre-dose and 204 days Post-dose (32 time points will be carried out within). ]

Other Outcome Measures:
  • Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Month 4 [ Time Frame: From Pre-dose to month 4; 3 timepoints Post-Dose 1, Pre-dose and 1 timepoint after Doses 2, 3 and 4 wtihin a timeframe of 28 days. ]

Enrollment: 70
Study Start Date: March 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gluteus (Risperidone ISM)
Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Drug: Risperidone ISM
Experimental: Deltoid (Risperdione ISM)
Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Drug: Risperidone ISM

  Eligibility

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

Inclusion Criteria:

  1. Capable of providing informed consent.
  2. Male or female aged ≥18 years to ≤65 years.
  3. Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual
  4. Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2.
  5. Medically stable over the last month, and psychiatrically stable
  6. On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
  7. Total score ≤70 on the Positive and Negative Syndrome Scale.
  8. Using a medically accepted contraceptive method
  9. Agrees to washout all prohibited medications prior to baseline (day -1)

Exclusion Criteria:

  1. Informed consent obtained from a third party.
  2. Prisoners or patients who are compulsorily detained.
  3. Females who are breast-feeding and/or who have a positive pregnancy test.
  4. Presence of an uncontrolled, unstable clinically significant medical condition.
  5. Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.
  6. History of neuroleptic malignant syndrome.
  7. Current or past history of tardive dyskinesia.
  8. Positive urine drug or alcohol screen finding.
  9. Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.
  10. Taking more than one antidepressant.
  11. Use of depot antipsychotics within the last three months.
  12. Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers
  13. Use of electroconvulsive therapy (ECT) within the last three months.
  14. Receipt of any investigational drugs within the last three months.
  15. Known or suspected allergy or hypersensitivity to risperidone
  16. Previous non-responder to risperidone treatment.
  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: NCT02086786

Locations
United States, Missouri
St. Louis, Missouri, United States, 63118
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
  More Information

Responsible Party: Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier: NCT02086786     History of Changes
Other Study ID Numbers: ROV-RISP-2011-02
Study First Received: February 10, 2014
Last Updated: May 4, 2015

Additional relevant MeSH terms:
Schizophrenia
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 May 25, 2017