SchizophreniaPhase 4NCT00159081
One Year Drug Treatment in First-Episode Schizophrenia
A Phase 4 study testing Haloperidol, Risperidone (drug) in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Haloperidol, Risperidone (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2000to Jun 2005
- 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
- After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
- Age between 18 and 55
- Informed consent
Who cannot join
- Residence outside of the catchment area
- 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 and Psychotherapy at the Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40629
About this study
Official title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.
Read the detailed description
The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).
- Conditions
- Schizophrenia
- Being tested
- Haloperidol, Risperidone (drug)
- Keywords
- Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol, Risperidone (drug)Drug
targeted dose of 2-4 mg/day over 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Maintenance antipsychotic treatment with risperidone Receives: Drug: Haloperidol, Risperidone (drug) |
| 2 | Active comparator | Maintenance antipsychotic treatment with haloperidol in low-dose Receives: Drug: Haloperidol, Risperidone (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
Measured: 1 year
Secondary outcomes (5)
course in psychopathology
Measured: 1 year
social and cognitive functioning
Measured: 1 year
side-effects
Measured: 1 year
drop-out
Measured: 1 year
quality of life
Measured: 1 year
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
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, University of München, 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
- Wolfgang Gaebel, Professor, Study chair, Department of Psychiatry and Psychotherapy, University of Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159081
- Sponsor's protocol ID
- 01GI 9932 - P 2.2.2.1 / 1
- Status last verified
- Jan 2008
- First submitted
- 7 Sep 2005
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. doi: 10.1007/s00406-004-0509-y.
PubMed 15146342Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116.
PubMed 18052570
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00159081
- Acronym / sponsor ID
- 01GI 9932 - P 2.2.2.1 / 1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, first episode, long-term treatment, typical vs. atypical neuroleptics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Janssen-Cilag Ltd., University of Bonn, Humboldt-Universität zu Berlin, University of München, 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
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- 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.
Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.
Detailed description
The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Haloperidol, Risperidone (drug)Maintenance antipsychotic treatment with risperidone |
| 2 | Active comparator | Drug: Haloperidol, Risperidone (drug)Maintenance antipsychotic treatment with haloperidol in low-dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
- Age between 18 and 55
- Informed consent
Key exclusion criteria (8 listed)
- Residence outside of the catchment area
- Legal reasons
- Insufficient knowledge of the German language
- Substance abuse or addiction
- Pregnancy
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 |
|---|---|---|
| Haloperidol, Risperidone (drug)targeted dose of 2-4 mg/day over 1 year | Drug | 1, 2 |
Primary outcome
relapse rate
Time frame: 1 year
5 secondary outcomes
course in psychopathology
Time frame: 1 year
social and cognitive functioning
Time frame: 1 year
side-effects
Time frame: 1 year
drop-out
Time frame: 1 year
quality of life
Time frame: 1 year
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 7 Feb 2008.
- Background: PubMed 15146342Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. doi: 10.1007/s00406-004-0509-y.
- Results publication: PubMed 18052570Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Jockers-Scherubl MC, Kuhn KU, Lemke M, Bechdolf A, Bender S, Degner D, Schlosser R, Schmidt LG, Schmitt A, Jager M, Buchkremer G, Falkai P, Klingberg S, Kopcke W, Maier W, Hafner H, Ohmann C, Salize HJ, Schneider F, Moller HJ; German Study Group on First-Episode Schizophrenia. Maintenance treatment with risperidone or low-dose haloperidol in first-episode schizophrenia: 1-year results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2007 Nov;68(11):1763-74. doi: 10.4088/jcp.v68n1116.
- Click here for more information about this study: One year maintenance treatment with low dose Haloperidol vs. Risperidone in first-episode schizophreniaLink 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.
Wolfgang Gaebel, Professor study chair
Department of Psychiatry and Psychotherapy, University of Duesseldorf
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 Haloperidol, Risperidone (drug) in people with Schizophrenia, run by Heinrich-Heine University, Duesseldorf 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 8 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 7 Feb 2008. 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?
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?
relapse rate (time frame: 1 year). 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 NCT00159081, which also lists 2 linked publications.
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 7 Feb 2008.