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SchizophreniaPhase 4NCT01685931

A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics

A Phase 4 study testing Paliperidone Palmitate in people with Schizophrenia, run by Xian-Janssen Pharmaceutical Ltd. at 17 sites in China.

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 assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone Palmitate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
617 participants
Where
17 sitesChina
Study dates
Nov 2012to Dec 2014
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previous diagnosis of schizophrenia
  • Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
  • Patients currently treated with antipsychotic are allowed to be recruited
  • Be medically stable on the basis of clinical laboratory tests performed at screening

Who cannot join

  • A primary diagnosis other than schizophrenia
  • History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
  • Clozapine use for treatment refractory schizophrenia
  • Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
  • Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Study site

    Baoding

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Chongqing

  • Study site

    Fuzhou

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Jinan

  • Study site

    Nanjing

  • Study site

    Qingdao

  • Study site

    Shantou

  • Study site

    Shenzhen

  • Study site

    Shijiazhuang

  • Study site

    Suzhou

  • Study site

    Taiyuan

  • Study site

    Tianjin

  • Study site

    Wuhan

Other trials in China

About this study

Official title: Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up

The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

Read the detailed description

This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.

Conditions
Schizophrenia
Being tested
Paliperidone Palmitate
Keywords
Schizophrenia, Paliperidone Palmitate, Oral Antipsychotics, Invega Sustenna
Medical subject headings
Schizophrenia

What participants receive

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

  • Paliperidone PalmitateDrug

    One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.

Study groups in NCT01685931
Study groupRoleWhat they receive
Paliperidone PalmitateExperimentalNot described
Receives: Drug: Paliperidone Palmitate

What is being measured

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

  1. The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)

    The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.

    Measured: Baseline, Week 13

Secondary outcomes (6)

  1. The change from baseline in Positive and Negative Syndrome Scale (PANSS) score

    The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.

    Measured: Baseline, Week 13

  2. The change from baseline in Clinical Global Impression - Severity (CGI-S)

    The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. 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 patients". Higher scores indicate worsening.

    Measured: Baseline, Week 13

  3. The change from baseline in Medication Satisfaction Questionnaire (MSQ)

    The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Baseline, Week 13

  4. The change from baseline in Involvement Evaluation Questionnaire (IEQ)

    The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).

    Measured: Baseline, Week 13

  5. The change from baseline in Medication Adherence Rating Scale (MARS)

    The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).

    Measured: Baseline, Week 13

  6. The change from baseline in Medication Preference Questionnaire (MPQ)

    The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.

    Measured: Baseline, Week 13

Timeline

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

  1. First posted14 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685931
Sponsor's protocol ID
CR100880
Other IDs
R092670SCH4019
Status last verified
Jan 2016
First submitted
11 Sep 2012
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paliperidone Palmitate in people with Schizophrenia, run by Xian-Janssen Pharmaceutical Ltd. at 17 sites in China.

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 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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?

The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline, Week 13). 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 NCT01685931.

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 26 Jan 2016.

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