An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders

Evaluation of Efficacy and Safety of Risperidone in Long-acting Microspheres in Patients With Schizophrenia, Schizophreniform or Schizoaffective Disorders Diagnosed According to the DSM-IV Criteria, After Switching Treatment With Any Antipsychotic Therapy With Long-acting Microspheres of Risperidone

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01855074

Enrollment

Registered

2013-05-16

Start date

2007-11-30

Completion date

2009-02-28

Last updated

2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Risperidone, Risperdal consta

Brief summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders (disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations).

Detailed description

This is an open-label (all people know the identity of the intervention), longitudinal (participants are followed over time with continuous or repeated monitoring of risk factors or health-outcomes), non-randomized (a clinical trial in which the participants are not assigned by chance to different treatment groups), single-center study to evaluate the efficacy and safety of long acting microspheres of risperidone in adult participants with schizophrenia, schizophreniform or schizoaffective disorders. The duration of this study will be 12 months and duration of treatment will be 6 months. The study will include 4 visits: Baseline, and 3 follow-up visits including Week 4, 12 and 26. All eligible participants will be treated with risperidone 25 milligram (mg) intramuscular injection (injection of a substance into a muscle) for every two weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) will be initiated with higher doses of risperidone. Doses will be adjusted according to the response of the treatment. Efficacy and safety of the participants will be primarily evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' quality of life and safety will be monitored throughout the study.

Interventions

DRUGRisperidone

Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptomatically stable participants defined as a) participants with treatment on outpatient and inpatient basis for at least 4 weeks before entering the study, and b) Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score less than or equal to (\<= ) 3 (1-7), including conceptual disorganization, suspicion, hallucinatory conduct and delirium (state of violent mental agitation) * Participants under antipsychotic treatment with extrapyramidal symptoms, persistent negative symptoms or lack of adherence defined as irregular administration of medication in the last 2 weeks * Participants who have given their informed consent in writing, or at least, by their family member or personal representative

Exclusion criteria

* Participants taking first antipsychotic treatment in his/her life * Participants with any other psychotic disorder different to the previously mentioned in the inclusion criteria * Pregnant or nursing women * History of neuroleptic malignant syndrome (potentially fatal syndrome associated primarily with the use of antipsychotic drugs and clinical features include diffuse muscle rigidity, tremor, high fever) or current symptoms of tardive dyskinesia (a neurological disorder characterized by involuntary movements of the face and jaw) * Participants with known intolerance or lack of response to risperidone

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26	Baseline and Week 26	The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.

Secondary

Measure	Time frame	Description
Clinical Global Impressions (CGI) - Disease Severity Score	Baseline and Week 26	The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening.
Short Form-36 (SF-36) - Quality of Life Score	Baseline and Week 26	The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).
Global Assessment of Functioning (GAF) Score	Baseline and Week 26	The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Patient Satisfaction With Treatment	Baseline and Week 26	Participants' were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.
Extrapyramidal Symptom Rating Scale (ESRS) Score	Baseline and Week 26	An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.

Participant flow

Participants by arm

Arm	Count
Risperidone Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months	79
Total	79

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Lost to Follow-up	4
Overall Study	Started but not treated	1
Overall Study	Withdrawal by Subject	8

Baseline characteristics

Characteristic	Risperidone
Age Continuous	43.0 Years STANDARD_DEVIATION 12.4
Sex: Female, Male Female	32 Participants
Sex: Female, Male Male	47 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 79
serious Total, serious adverse events	1 / 79

Outcome results

Primary

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.