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SchizophreniaPhase 4NCT00526877

An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment

A Phase 4 study testing Risperidone in people with Schizophrenia and Schizoaffective Disorders, run by Johnson & Johnson Taiwan Ltd at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia, Schizoaffective Disorders
What is being tested?
Risperidone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteTaiwan
Study dates
13 Jul 2007to 31 Jan 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres

The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) and schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), who are receiving psychiatric home-care treatment .

Read the detailed description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-randomized and single-arm study of long- acting risperidone microspheres in participants with schizophrenia and schizoaffective disorders. The duration of this study will be 6 months and will include following parts: Screening (that is, 28 days before study commences on Day 1), run-in period (that is, Week 1 to 3) and Treatment period (that is, Week 1 to 24). Participants will receive previous medication for the first three weeks during run-in period and previous medications will be tapered off during the third week. Participants will receive long-acting risperidone microspheres starting at a dose of 25 milligram (mg) every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale.

Being tested
Risperidone
Keywords
Schizophrenia, Schizoaffective disorders, Risperidone, Risperdal Consta
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisperidoneDrug

    Also called Risperdal Consta

    Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.

Study groups in NCT00526877
Study groupRoleWhat they receive
RisperidoneExperimentalRisperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.
Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24

    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.

    Measured: Baseline and Week 24

Secondary outcomes (6)

  1. Personal and Social Performance (PSP) Scale Score

    The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.

    Measured: Screening (28 days before study drug administration), Baseline and Week 24

  2. Clinical Global Impression (CGI) Scale Score

    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 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.

    Measured: Screening (28 days before study drug administration), Baseline and Week 24

  3. Short Form-36 (SF-36) - Quality of Life Score

    The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.

    Measured: Screening (28 days before study drug administration), Baseline and Week 24

  4. Change From Baseline in Simpson Angus Rating Scale (SAS) Score at Week 24

    The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.

    Measured: Baseline and Week 24

  5. Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Week 24

    The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).

    Measured: Baseline and Week 24

  6. Number of Participants Compliant With Study Treatment

    Participants compliant with study treatment will be the participants who will complete the study treatment regimen.

    Measured: 6 months before administration of study drug and 6 months after administration of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study start13 Jul 2007
  3. Primary completion31 Jan 2009
  4. Study completion31 Jan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526877
Sponsor's protocol ID
CR013873
Other IDs
RISSCH4119
Status last verified
Jun 2026
First submitted
6 Sep 2007
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risperidone in people with Schizophrenia and Schizoaffective Disorders, run by Johnson & Johnson Taiwan Ltd at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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