New Long-Acting shot for schizophrenia shows promise in small study
NCT ID NCT00526877
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a long-acting injectable form of risperidone (Risperdal Consta) in 31 people with schizophrenia or schizoaffective disorder who were already receiving home-care treatment. Participants switched from their usual antipsychotic medication to receive a shot every two weeks for 24 weeks. The goal was to see if the long-acting injection could effectively control symptoms and be safe, using standard rating scales to measure changes in symptoms and social functioning.
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 offer a more convenient treatment option for people with schizophrenia or schizoaffective disorder, potentially improving medication adherence and symptom control.
- What could go wrong
- This is a small, completed Phase 4 study with only 31 participants, so results may not apply to everyone. Long-acting antipsychotics can have side effects like movement disorders or metabolic changes.
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
-
31 people
The number who actually took part.
- Started
-
Jul 2007
- Finished
-
Jan 2009
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
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: * Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) * Participant has been given an adequate dose of an appropriate antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsatisfactory due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication * Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine betahuman chorionic gonadotropin (HCG) pregnancy test at screening; and a negative urine pregnancy test on screening visit * Participants or their legally acceptable representatives must have signed an informed consent document Exclusion Criteria: * Participants with a primary, active DSM-IV diagnosis other than schizophrenia and schizoaffective disorder * Participants with relevant history or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic or other systemic disease * Participants that are previously on concomitant use of Risperdal CONSTA * History or current symptoms of tardive dyskinesia * History of neuroleptic malignant syndrome (NMS)
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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
-
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Other studies related to the condition(s) this trial covers.
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