CClinicalTrials.gg
TerminatedNCT00314327ORPUpdated May 16, 2018Results posted

Optimizing Response in Psychosis Study

A Phase 4 interventional study of long-acting injectable risperidone in Schizophrenia, Schizoaffective Disorder and Schizophreniform Disorder, sponsored by Northwell Health. Terminated at 2 sites in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-05-16.

Sponsored by Northwell Health · Phase 4, Interventional, and Treatment

Why this study was terminated
Recruitment for the study was limited.
Phase
Phase 4
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
15 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Psychotic Disorder Not Otherwise Specified

Keywords

  • first episode
  • schizophrenia
  • risperidone
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 1 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    long-acting injectable risperidone

    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.

    Drug: long-acting injectable risperidone

Interventions

  • Druglong-acting injectable risperidone

    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.

    Also known as: Risperdal (oral) & Risperdal Consta

06

What researchers measure

Primary outcomes

  1. Treatment Response Based Upon BPRS and CGI Ratings

    Time frame: 13 weeks

Secondary outcomes

  1. 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

    Time frame: 13 weeks

07

Results

Posted Apr 29, 2015

Participant flow

Participant flow — Overall Study
MilestoneLong-acting Injectable Risperidone
Started1
Completed0
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryTreatment Response Based Upon BPRS and CGI Ratings
Time frame:
13 weeks

No measurements were reported for this outcome.

SecondaryNegative 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

Time frame:
13 weeks

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Long-acting Injectable Risperidone—0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Long-acting Injectable Risperidone
Mean19
Sex: Female, Male
Sex: Female, Male(Participants)Long-acting Injectable Risperidone
Female0
Male1
Region of Enrollment
Region of Enrollment(participants)Long-acting Injectable Risperidone
United States1
08

Study locations

2 sites
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
  • The Zucker Hillside Hospital
    Glen Oaks, New York 11004, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00314327
Lead sponsor
Northwell Health
Collaborators
The Zucker Hillside Hospital, National Alliance for Research on Schizophrenia and Depression
Responsible party
Delbert Robinson (MD, Northwell Health) — Principal investigator
First posted
Apr 13, 2006
Start date
Apr 2006
Primary completion
Nov 2013
Completion
Nov 2013
Results posted
Apr 29, 2015
Last update
May 16, 2018

Study contacts

Delbert G Robinson, M.D.
principal investigator · The North Shore-Long Island Jewish Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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