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
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.
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.
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 →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.
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Exclusion criteria:
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
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
Treatment Response Based Upon BPRS and CGI Ratings
Time frame: 13 weeks
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
| Milestone | Long-acting Injectable Risperidone |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Long-acting Injectable Risperidone | — | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | Long-acting Injectable Risperidone |
|---|---|
| Mean | 19 |
| Sex: Female, Male(Participants) | Long-acting Injectable Risperidone |
|---|---|
| Female | 0 |
| Male | 1 |
| Region of Enrollment(participants) | Long-acting Injectable Risperidone |
|---|---|
| United States | 1 |
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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