Schizophrenia, First-EpisodePhase 4NCT00157378
Optimization of Acute Treatment in First Episode Schizophrenia
A Phase 4 study testing Risperidone, Haloperidol in people with Schizophrenia, First-Episode, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, First-Episode
- What is being tested?
- Risperidone, Haloperidol
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2000to Dec 2004
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ICD-10 criteria for first episode schizophrenia
- age between 18 and 55
- informed consent
Who cannot join
- legal reasons
- insufficient knowledge of the german language
- substance abuse or addiction
- pregnancy
- serious physical illness
- organic brain disease
- contraindication to neuroleptic treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, Ludwig-Maximilians-University
Munich, 80336
About this study
Official title: Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments
The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).
Read the detailed description
Considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics, the study aims to reach neuroleptic response under the lowest possible dosage of the study medication (haloperidol or risperidone). Therefore the initial dosage of the study medication is 2 mg/d. Depending on the patients' symptomatology, the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mg/d. Patients with the diagnosis of schizophrenia (F20, according to ICD-10-criteria) are consecutively enrolled in the study. The patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks. Apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study. Major questions of the study are, whether patients, who have been treated with risperidone compared with those, who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects. Furthermore it is hypothesised, that the treatment with Risperidone has better effects on cognitive disorders/dysfunctions and depressive symptoms and that the patients, who receive Risperidone are more compliant and have a higher quality of life.
- Conditions
- Schizophrenia, First-Episode
- Being tested
- Risperidone, Haloperidol
- Keywords
- first episode,, schizophrenia,, atypical neuroleptics,, negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone, HaloperidolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
weekly assessment of psychopathology (e.g.PANSS)and side-effects
Secondary outcomes (3)
cognitive disability
depression
life quality at time of admission & end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, First-EpisodeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd., German Research Network On Schizophrenia, Department of Psychiatry University of Bonn, Heinrich-Heine University, Duesseldorf, Department of Psychiatry University FU Berlin, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
- Investigators
- Hans-Jürgen Möller, Professor, Study chair, Department of Psychiatry, Ludwig-Maximilians-University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157378
- Sponsor's protocol ID
- 01GI9933-P2.1.2.1
- Status last verified
- Jan 2000
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments
- ClinicalTrials.gov ID
- NCT00157378
- Acronym / sponsor ID
- 01GI9933-P2.1.2.1
- Conditions
- Schizophrenia, First-Episode
- Keywords
- first episode,, schizophrenia,, atypical neuroleptics,, negative symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd., German Research Network On Schizophrenia, Department of Psychiatry University of Bonn, Heinrich-Heine University, Duesseldorf, Department of Psychiatry University FU Berlin, University of Göttingen, University of Cologne, Mainz University, University Hospital Tuebingen, Universität Duisburg-Essen, University of Mannheim, University of Jena, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, University of Wuerzburg
- Study start
- Nov 2000
- Study completion
- Dec 2004
- First posted
- 12 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 study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).
Detailed description
Considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics, the study aims to reach neuroleptic response under the lowest possible dosage of the study medication (haloperidol or risperidone). Therefore the initial dosage of the study medication is 2 mg/d. Depending on the patients' symptomatology, the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mg/d. Patients with the diagnosis of schizophrenia (F20, according to ICD-10-criteria) are consecutively enrolled in the study. The patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks. Apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study. Major questions of the study are, whether patients, who have been treated with risperidone compared with those, who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects. Furthermore it is hypothesised, that the treatment with Risperidone has better effects on cognitive disorders/dysfunctions and depressive symptoms and that the patients, who receive Risperidone are more compliant and have a higher quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ICD-10 criteria for first episode schizophrenia
- age between 18 and 55
- informed consent
Key exclusion criteria (7 listed)
- legal reasons
- insufficient knowledge of the german language
- substance abuse or addiction
- pregnancy
- serious physical illness
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 |
|---|---|---|
| Risperidone, Haloperidol | Drug | – |
Primary outcome
weekly assessment of psychopathology (e.g.PANSS)and side-effects
3 secondary outcomes
cognitive disability
depression
life quality at time of admission & end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
- Related InfoLink provided by the sponsor.
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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.
Hans-Jürgen Möller, Professor study chair
Department of Psychiatry, Ludwig-Maximilians-University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone, Haloperidol in people with Schizophrenia, First-Episode, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Sep 2005. 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 Germany. 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?
Results are not available in the source record.
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?
weekly assessment of psychopathology (e.g.PANSS)and side-effects. 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 Sep 2005.