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Optimizing Response in Psychosis Study (ORP)

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
long-acting injectable risperidone
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring first episode, schizophrenia, risperidone

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1998) Is in the first episode of illness. First episode is defined as having had 6 months or less of lifetime treatment with an antipsychotic. Has not responded sufficiently to treatment with an antipsychotic. Lack of response is defined as a rating at study entry of 4 (moderate) or more on at least one of the following BPRS-A items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content. Continuous antipsychotic treatment at the time of study entry of a minimum of 12 weeks with the same antipsychotic agent. Antipsychotic dosing at some point during the 12 weeks must have reached a sufficient dose for antipsychotic response (e.g. patients who received only low dose quetiapine for insomnia or anxiety would not qualify). Sufficient dose for second generation antipsychotics is defined as a minimum dose of risperidone 3 mg/day, olanzapine 10 mg/day, quetiapine 500 mg/day, ziprasidone 100 mg/day or aripiprazole 15 mg/day. Sufficient dose for first generation antipsychotics is defined as 3 mg/day of haloperidol or its equivalent for other first generation agents. Aged 15 to 40. If age 18 or older, competent and willing to sign informed consent. If under age 18, parent or guardian consent and subject assent. For women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control. Exclusion criteria: Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features. Persistence of psychotic symptoms due to nonadherence to antipsychotic medication. Medical contraindications to treatment with long-acting injectable risperidone. Serious neurological or endocrine disorder or medical condition /treatment known to affect the brain. A medical condition requiring medication with psychotropic effects. Clinical assessment that trial participation is contraindicated due to risk for homicidal or suicidal behavior. A diagnosis of diabetes (fasting glucose > 126 mg/dl). Requires with antidepressant or mood stabilizing medication. Previous treatment with a long acting formulation of an antipsychotic

Sites / Locations

  • SUNY Downstate Medical Center
  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

long-acting injectable risperidone

Arm Description

One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.

Outcomes

Primary Outcome Measures

Treatment Response Based Upon BPRS and CGI Ratings

Secondary Outcome Measures

Negative Symptoms
Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized. The negative symptoms that were going to be analyzed include: Affective Flattening, Alogia, Avolition /Apathy, and Anhedonia/Asociality

Full Information

First Posted
April 11, 2006
Last Updated
April 18, 2018
Sponsor
Northwell Health
Collaborators
The Zucker Hillside Hospital, National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00314327
Brief Title
Optimizing Response in Psychosis Study
Acronym
ORP
Official Title
Optimizing Response in Psychosis Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment for the study was limited.
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
The Zucker Hillside Hospital, National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.
Detailed Description
The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic. The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorder Not Otherwise Specified
Keywords
first episode, schizophrenia, risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
long-acting injectable risperidone
Arm Type
Experimental
Arm Description
One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Intervention Type
Drug
Intervention Name(s)
long-acting injectable risperidone
Other Intervention Name(s)
Risperdal (oral) & Risperdal Consta
Intervention Description
One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Primary Outcome Measure Information:
Title
Treatment Response Based Upon BPRS and CGI Ratings
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Negative Symptoms
Description
Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized. The negative symptoms that were going to be analyzed include: Affective Flattening, Alogia, Avolition /Apathy, and Anhedonia/Asociality
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1998) Is in the first episode of illness. First episode is defined as having had 6 months or less of lifetime treatment with an antipsychotic. Has not responded sufficiently to treatment with an antipsychotic. Lack of response is defined as a rating at study entry of 4 (moderate) or more on at least one of the following BPRS-A items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content. Continuous antipsychotic treatment at the time of study entry of a minimum of 12 weeks with the same antipsychotic agent. Antipsychotic dosing at some point during the 12 weeks must have reached a sufficient dose for antipsychotic response (e.g. patients who received only low dose quetiapine for insomnia or anxiety would not qualify). Sufficient dose for second generation antipsychotics is defined as a minimum dose of risperidone 3 mg/day, olanzapine 10 mg/day, quetiapine 500 mg/day, ziprasidone 100 mg/day or aripiprazole 15 mg/day. Sufficient dose for first generation antipsychotics is defined as 3 mg/day of haloperidol or its equivalent for other first generation agents. Aged 15 to 40. If age 18 or older, competent and willing to sign informed consent. If under age 18, parent or guardian consent and subject assent. For women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control. Exclusion criteria: Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features. Persistence of psychotic symptoms due to nonadherence to antipsychotic medication. Medical contraindications to treatment with long-acting injectable risperidone. Serious neurological or endocrine disorder or medical condition /treatment known to affect the brain. A medical condition requiring medication with psychotropic effects. Clinical assessment that trial participation is contraindicated due to risk for homicidal or suicidal behavior. A diagnosis of diabetes (fasting glucose > 126 mg/dl). Requires with antidepressant or mood stabilizing medication. Previous treatment with a long acting formulation of an antipsychotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delbert G Robinson, M.D.
Organizational Affiliation
The North Shore-Long Island Jewish Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.narsad.org
Description
web site of NARSAD

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Optimizing Response in Psychosis Study

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