SchizophreniaPhase 4NCT00159120
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
A Phase 4 study testing maintained antipsychotic treatment vs. stepwise drug discontinuation in people with Schizophrenia and Psychoses, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Psychoses
- What is being tested?
- maintained antipsychotic treatment vs. stepwise drug discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2001to Jun 2006
- 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
- Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
- Age between 18 and 55
- Informed consent
- One year neuroleptic maintenance treatment
- Reaching stable course
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
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40629
About this study
Official title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.
Read the detailed description
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.
- Conditions
- Schizophrenia, Psychoses
- Being tested
- maintained antipsychotic treatment vs. stepwise drug discontinuation
- Keywords
- Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention
- 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.
maintained antipsychotic treatment vs. stepwise drug discontinuationOther
maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | further maintenance antipsychotic treatment and prodrome-based early intervention Receives: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation |
| 2 | Experimental | stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention Receives: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation |
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)
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 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 71 participants (estimated)
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, Ludwig-Maximilians - University of Munich, 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 at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159120
- Sponsor's protocol ID
- 01GI 9932 - P 2.2.2.1 / 2
- Status last verified
- Jan 2008
- First submitted
- 7 Sep 2005
- Last updated
- 30 Jan 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 15146342Seemuller F, Schennach R, Mayr A, Musil R, Jager M, Maier W, Klingenberg S, Heuser I, Klosterkotter J, Gastpar M, Schmitt A, Schlosser R, Schneider F, Ohmann C, Lewitzka U, Gaebel W, Moller HJ, Riedel M; German Study Group on First-Episode Schizophrenia. Akathisia and suicidal ideation in first-episode schizophrenia. J Clin Psychopharmacol. 2012 Oct;32(5):694-8. doi: 10.1097/JCP.0b013e3182677958.
PubMed 22926606Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Lemke M, Heuser I, Maier W, Huff W, Schmitt A, Sauer H, Riedel M, Klingberg S, Kopcke W, Ohmann C, Moller HJ; German Study Group on First-Episode Schizophrenia. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2011 Feb;72(2):205-18. doi: 10.4088/JCP.09m05459yel. Epub 2010 Jun 29.
PubMed 20673559
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00159120
- Acronym / sponsor ID
- 01GI 9932 - P 2.2.2.1 / 2
- Conditions
- Schizophrenia, Psychoses
- Keywords
- Schizophrenia, first episode, neuroleptic maintenance treatment, drug discontinuation, prodrome based early intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- 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, Ludwig-Maximilians - University of Munich, 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 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (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.
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.
Detailed description
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: maintained antipsychotic treatment vs. stepwise drug discontinuationfurther maintenance antipsychotic treatment and prodrome-based early intervention |
| 2 | Experimental | Other: maintained antipsychotic treatment vs. stepwise drug discontinuationstepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
- Age between 18 and 55
- Informed consent
- One year neuroleptic maintenance treatment
- Reaching stable course
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 |
|---|---|---|
| maintained antipsychotic treatment vs. stepwise drug discontinuationmaintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year | Other | 1, 2 |
Primary outcome
relapse rate
Time frame: 1 year
5 secondary outcomes
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 30 Jan 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.
- Derived from this study: PubMed 22926606Seemuller F, Schennach R, Mayr A, Musil R, Jager M, Maier W, Klingenberg S, Heuser I, Klosterkotter J, Gastpar M, Schmitt A, Schlosser R, Schneider F, Ohmann C, Lewitzka U, Gaebel W, Moller HJ, Riedel M; German Study Group on First-Episode Schizophrenia. Akathisia and suicidal ideation in first-episode schizophrenia. J Clin Psychopharmacol. 2012 Oct;32(5):694-8. doi: 10.1097/JCP.0b013e3182677958.
- Derived from this study: PubMed 20673559Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Lemke M, Heuser I, Maier W, Huff W, Schmitt A, Sauer H, Riedel M, Klingberg S, Kopcke W, Ohmann C, Moller HJ; German Study Group on First-Episode Schizophrenia. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2011 Feb;72(2):205-18. doi: 10.4088/JCP.09m05459yel. Epub 2010 Jun 29.
- Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention 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 at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
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 maintained antipsychotic treatment vs. stepwise drug discontinuation in people with Schizophrenia and Psychoses, 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 5 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 30 Jan 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 NCT00159120, which also lists 3 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 30 Jan 2008.