SchizophreniaPhase 4NCT00199940
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
A Phase 4 study testing Ziprasidone in people with Schizophrenia and Affective Disorders, run by Medical College of Wisconsin.
Trial summary
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Schizophrenia, Affective Disorders, Psychotic Disorder
- What is being tested?
- Ziprasidone
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Apr 2007
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Schizophrenia, Schizophreniform DO, Schizoaffective DO or Psychotic Disorder NOS
- Male/female, ages 7.0-17 years old
- Normal intelligence, ability to provide assent and consent
- Not currently receiving adequate treatment
Who cannot join
- Known hypersensitivity to ziprasidone (past failed trial)
- History of QTc prolongation
- Recent myocardial infarction
- Uncompensated heart failure
- Currently treated with other QTc prolonging medications
- Unstable medical illness
- If on diuretics, monitor regularly for hypokalemia
About this study
Official title: A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children.
Read the detailed description
Ziprasidone is a recently FDA approved antipsychotic, and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects. This is important because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome. Unfortunately, pediatric samples are often more sensitive to the side effects of psychotropic medications. Because psychotropic medications are often used by clinicians long before they are studied in pediatric populations, it is important to further study these agents.
Twenty subjects with the diagnosis of a psychotic disorder, according to DSM-IV criteria, will be recruited for the study. If subjects have completed baseline evaluations, labs, EKG, and rating scales and are still eligible to participate, subjects will start on 20mg of Ziprasidone at night. The second week this will increase to 20 mg twice a day. At visits that occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day increments. This allows for a maximum possible dose of 100mg. Dosage may be decreased at any time secondary to side effects.
The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis. The potential benefits of this study outweigh the possible risks.
- Being tested
- Ziprasidone
- Keywords
- Schizophrenia, Pediatric psychotic disorders, Ziprasidone
- Medical subject headings
- Schizophrenia, Mood Disorders, Psychotic Disorders, Affective Disorders, Psychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale (PANSS), score symptoms from baseline through end of study Week 8.
Secondary outcomes (6)
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), assess at baseline only.
Child Depression Rating Scale (CDRS), rate from baseline to Week 8.
Simpson-Angus Rating Scale (SARS), rate from baseline to Week 8.
Abnormal Involuntary Movement Scale (AIMS), rate at baseline, Weeks 2,4,6,8.
Barnes Akathesia Scale (BAS), rate from baseline through Week 8.
Side-Effect For Children & Adolescents (SEFCA), rate from baseline through Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Investigators
- Russell E Scheffer, MD, Principal investigator, Medical College of Wisconsin; Children's Hospital of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199940
- Sponsor's protocol ID
- CHW 03/162, HRRC 538-03
- Status last verified
- Mar 2008
- First submitted
- 13 Sep 2005
- Last updated
- 12 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open Trial Of Ziprasidone, Early In The Course Of Pediatric Psychotic Illness
- ClinicalTrials.gov ID
- NCT00199940
- Acronym / sponsor ID
- CHW 03/162, HRRC 538-03
- Keywords
- Schizophrenia, Pediatric psychotic disorders, Ziprasidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children.
Detailed description
Ziprasidone is a recently FDA approved antipsychotic, and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects. This is important because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome. Unfortunately, pediatric samples are often more sensitive to the side effects of psychotropic medications. Because psychotropic medications are often used by clinicians long before they are studied in pediatric populations, it is important to further study these agents.
Twenty subjects with the diagnosis of a psychotic disorder, according to DSM-IV criteria, will be recruited for the study. If subjects have completed baseline evaluations, labs, EKG, and rating scales and are still eligible to participate, subjects will start on 20mg of Ziprasidone at night. The second week this will increase to 20 mg twice a day. At visits that occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day increments. This allows for a maximum possible dose of 100mg. Dosage may be decreased at any time secondary to side effects.
The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis. The potential benefits of this study outweigh the possible risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Schizophrenia, Schizophreniform DO, Schizoaffective DO or Psychotic Disorder NOS
- Male/female, ages 7.0-17 years old
- Normal intelligence, ability to provide assent and consent
- Not currently receiving adequate treatment
Key exclusion criteria (7 listed)
- Known hypersensitivity to ziprasidone (past failed trial)
- History of QTc prolongation
- Recent myocardial infarction
- Uncompensated heart failure
- Currently treated with other QTc prolonging medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziprasidone | Drug | – |
Primary outcome
Positive and Negative Symptom Scale (PANSS), score symptoms from baseline through end of study Week 8.
6 secondary outcomes
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), assess at baseline only.
Child Depression Rating Scale (CDRS), rate from baseline to Week 8.
Simpson-Angus Rating Scale (SARS), rate from baseline to Week 8.
Abnormal Involuntary Movement Scale (AIMS), rate at baseline, Weeks 2,4,6,8.
Barnes Akathesia Scale (BAS), rate from baseline through Week 8.
Side-Effect For Children & Adolescents (SEFCA), rate from baseline through Week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell E Scheffer, MD principal investigator
Medical College of Wisconsin; Children's Hospital of Wisconsin
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziprasidone in people with Schizophrenia and Affective Disorders, run by Medical College of Wisconsin.
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 7 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 12 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Positive and Negative Symptom Scale (PANSS), score symptoms from baseline through end of study Week 8.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2008.