NCT01788774

Brief Summary

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Apr 2013

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

February 5, 2013

Last Update Submit

October 19, 2023

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

PharmacokineticsSafetyRisperidone ISM®IntramuscularSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Area under the curve

    Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame

Study Arms (3)

Risperidone ISM 50mg

OTHER

Three different single doses will be evaluated

Drug: Risperidone ISM 50 mg

Risperidone ISM 75mg

OTHER

Three different single doses will be evaluated

Drug: Risperidone ISM 75 mg

Risperidone ISM 100mg

OTHER

Three different single doses will be evaluated

Drug: Risperidone ISM 100 mg

Interventions

Risperidone ISM 50 mgDRUG
Risperidone ISM 50mg
Risperidone ISM 75 mgDRUG
Risperidone ISM 75mg
Risperidone ISM 100 mgDRUG
Risperidone ISM 100mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Barcelona, Spain

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 11, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 23, 2023

Record last verified: 2014-10

Locations

CR(1)ZA(1)ES(1)RU(2)