Phase 4
Completed N=83
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Source: ClinicalTrials.gov NCT00330551 ↗Enrolled (actual)
83
Serious AEs
12.0%
Results posted
Mar 2020
Primary outcomePrimary: Medication Adherence — 1.1; 1.9 units on a scale — p==.05
◆ Published Evidence
Highly cited
257citations · ~23 / year
Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial.
Summary
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
Linked Publications (2)
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Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial.
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Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence |
1.1; 1.9 | =.05 |
| PRIMARY Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms |
2; 14 | =.001 sig |
| PRIMARY Number of Participants Who Returned to Work or School (SAS Work Section) |
29; 29 | =.83 |
| PRIMARY Number of Weeks Maintaining Work or School (SAS) |
26.7; 21.1 | =.20 |
| PRIMARY Change in Global Functioning Scale: Role |
1.5; 1.2 | .71 |
| SECONDARY MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score |
3.5; 4.4 | =.57 |
| SECONDARY Emotional Reactivity on Psychophysiological Measures |
— | — |
| SECONDARY Retention in Treatment |
307.6; 270.7 | <.16 |
| SECONDARY Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R) |
.07; -.24 | =.41 |
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study entry
- Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia
Exclusion Criteria
- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
- Mental retardation (e.g., premorbid IQ less than 70)
- Significant alcohol or substance abuse within 6 months prior to study entry
- Inability to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
Data sourced from ClinicalTrials.gov (NCT00330551) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.