Could a stronger dose of risperidone help when standard treatment fails?
NCT ID NCT00539071
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a higher dose of the long-acting injectable medication risperidone (Risperdal Consta) works better than the usual dose for people with schizophrenia or schizoaffective disorder who still have symptoms despite standard treatment. 160 participants received either 50 mg or 75-100 mg every two weeks, and their symptom changes were measured over 24 weeks. The goal was to see if the higher dose improves symptom control without causing more side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- risperidone (long-acting injectable)
- What this could lead to
- If successful, this could show that a higher dose of long-acting risperidone helps control symptoms better in people who haven't responded well to standard doses.
- What could go wrong
- This is a small Phase 4 trial with only 160 participants, so results may not apply to everyone. Higher doses may also increase side effects like drowsiness or movement problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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160 people
The number who actually took part.
- Started
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Mar 2008
- Finished
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May 2012
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients diagnosed with schizophrenia or schizoaffective disorder * Able to give written informed consent. * Moderate psychosis persists although compliant with medication * Patients must have an inadequate response to two antipsychotic medications (can be risperidone, oral or long acting - but not required), at doses that are within the upper end of the standard dosage range * Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity and a Personal and Social Performance Scale (PSP) score of 60 or below. * At the time of screening, eligible patients will be receiving or have received treatment with risperidone oral or Consta, or a combination that does not exceed 50 mg q 2 weeks of Consta or oral risperidone 8 mg/day for at least 6 weeks within seven years of study entry without satisfactory response as documented in the medical record Risperidone * Patients who have received Consta injectable medication within the specified dose range for no more than a month prior to the onset of the study will be eligible. Patients receiving mood stabilizers or antidepressants, or both, in addition to risperidone oral or Consta, will be eligible * Patients may initially be inpatients or outpatients * Females of childbearing potential will be admitted only if they are on stable birth control medication and understand that they should not get pregnant during the course of the study. * All patients must have stable housing at the current time or plans for housing following hospital discharge, if an inpatient. * Patients must be willing to receive injectable medication Exclusion Criteria: * Patients with a diagnosis other than schizophrenia or schizoaffective disorder. * Patients previously treated with doses of these agents higher than those allowed for at least six months and who failed to have an adequate response will be excluded * Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 3 months * Pregnant females. Females who are currently breastfeeding will be excluded. * Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment. * Patient with worse than mild tardive dyskinesia or history of marked Extrapyramidal Symptoms (EPS) at screening * Patients who have had neuroleptic malignant syndrome * Patients with a history of galactorrhea * Patients with uncontrolled medical condition(s) * Patients with a history of non-compliance to oral or injectable medication. * Patients unwilling to have injectable medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212-8645, United States
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