Clinical trial NCT00330551: Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Official title: Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizoaffective Disorder, Depressed Type
Schizophreniform Disorder
First-episode Schizophrenia
Injectable Risperidone
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Janssen Scientific Affairs, LLC
First posted: 2006-05-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Detailed description: Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

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

Primary outcomes:
measure: Medication Adherence
timeFrame: Measured weekly throughout study participation, averaged over study participation
measure: Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms
timeFrame: Occurrence after randomization and until end of study participation (up to 12 mos.)
measure: Number of Participants Who Returned to Work or School (SAS Work Section)
timeFrame: Measured from Baseline to Month 12
measure: Number of Weeks Maintaining Work or School (SAS)
timeFrame: Cumulative total measured from Baseline to Month 12
measure: Change in Global Functioning Scale: Role
timeFrame: Measured at Baseline and Month 12
Secondary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
timeFrame: Measured at baseline and 12 months
measure: Emotional Reactivity on Psychophysiological Measures
timeFrame: Measured from Baseline to Month 12
measure: Retention in Treatment
timeFrame: From baseline to 12 months
measure: Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Semel Institute for Neuroscience and Human Behavior at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
name: Keith H. Nuechterlein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.
citation: Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. doi: 10.1016/j.schres.2011.06.029. Epub 2011 Jul 20.