SchizophreniaPhase 4NCT02307396

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

A Phase 4 study testing Olanzapine, Amisulpride and Risperidone in people with Schizophrenia and Schizophrenia and Disorders With Psychotic Features, run by Technical University of Munich at 1 site in Germany.

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 main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders
What is being tested?: Olanzapine, Amisulpride and Risperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteGermany
Study dates: 1 Feb 2015to 22 Jun 2016
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

Diagnosis of schizophrenia or schizoaffective disorder
The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005) Score ≤3 for the items concerning psychosis of the "Positive and Negative Syndrom Scale" (PANSS; Kay et al., 1987): "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) and a score ≤3 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976)
Able to give informed consent

Who cannot join

Actively suicidal
Serious medical illnesses
Known non-complience concerning the medication
Medication with clozapin
Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment
Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline
Unability to give informed consent
Pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial

Read the detailed description

The main objective of the trial is to evaluate for the first time, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a guided withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome. We include patients with schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication.

Conditions: Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders
Being tested: Olanzapine, Amisulpride, Risperidone, Haloperidol, Quetiapine
Medical subject headings: Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders

What participants receive

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

OlanzapineDrug
AmisulprideDrug
RisperidoneDrug
HaloperidolDrug
QuetiapineDrug
PerphenazineDrug
SulpirideDrug
bromperidolDrug
ZuclopenthixolDrug
ThioridazineDrug
PaliperidoneDrug
ZiprasidoneDrug
BenperidolDrug
FluspirileneDrug
PimozideDrug
PerazineDrug
FluphenazineDrug
FlupentixoleDrug
SertindoleDrug

Study groups in NCT02307396
Study group	Role	What they receive
Intervention	Experimental	Intervention group: guided discontinuation or dose-reduction of the current antipsychotic medication. The antipsychotic drug used before study start will be discontinued gradually under medical surveillance. The process of discontinuation depends on the physicians judgement und should be guided be the participants needs and clinical status. This approach was already used before in another study ("gradual discontinuation", Wunderink et al., 2007). We assume that the dose can be reduced by approximately 1/6 of the starting dose every two weeks. If long acting antipsychotics are applied, there is no need for a gradual discontinuation due to their long half life. Receives: Drug: Olanzapine; Drug: Amisulpride; Drug: Risperidone; Drug: Haloperidol; Drug: Quetiapine; Drug: Perphenazine; Drug: Sulpiride; Drug: bromperidol; Drug: Zuclopenthixol; Drug: Thioridazine; Drug: Paliperidone; Drug: Ziprasidone; Drug: Benperidol; Drug: Fluspirilene; Drug: Pimozide; Drug: Perazine; Drug: Fluphenazine; Drug: Flupentixole; Drug: Sertindole
Control	Active comparator	The participants receive the same antipsychotic drugs, they have received before the start of the study, without changing the dose or the application form. Study medication is, with exception of Clozapin, every oral or depot neuroleptic drug approved for the treatment of schizophrenia in Germany. Receives: Drug: Olanzapine; Drug: Amisulpride; Drug: Risperidone; Drug: Haloperidol; Drug: Quetiapine; Drug: Perphenazine; Drug: Sulpiride; Drug: bromperidol; Drug: Zuclopenthixol; Drug: Thioridazine; Drug: Paliperidone; Drug: Ziprasidone; Drug: Benperidol; Drug: Fluspirilene; Drug: Pimozide; Drug: Perazine; Drug: Fluphenazine; Drug: Flupentixole; Drug: Sertindole

What is being measured

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

Relapse
The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled:
1. Score ≥4 (moderate) for at least two of the following PANSS-items : "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) (PANSS; Kay et al., 1987)
2. Score ≥4 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976b)
Measured: Every 2 weeks up to 26 weeks

Secondary outcomes (11)

Psychiatric rehospitalisation
Measured: Every 2 weeks up to 26 weeks
Totalscore of Positive and Negative Syndrome Scale (PANSS)
PANSS-Scale
Measured: Baseline, then every 4 weeks up to 26 weeks
Occurence of specific adverse effects (open interview)
Measured: Baseline,then every 4 weeks up to 26 weeks
Clinical Global Impression - Severity Scale (CGI-S)
CGI-I Scale
Measured: Baseline, then every 4 weeks up to 26 weeks
"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
SW-N-Scale
Measured: Baseline, and after 12 and 26 weeks
Status of occupation
Measured: Baseline, and after 12 and 26 weeks
Personal and Social Performance (Personal and Social Performance Scale [PSP])
PSP-Scale
Measured: Baseline, and after 12 and 26 weeks
Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
MARS-Scale
Measured: Baseline, and after 12 and 26 weeks
Drop-outs total and due to specific reasons
Measured: Every 2 weeks up to 26 weeks
Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
AIMS-Scale
Measured: Baseline, and after 12 and 26 weeks
Weight change
Measured: Baseline, and after 12 and 26 weeks

Timeline

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

1 Feb 201522 Jun 2016

First posted4 Dec 2014 (estimated)
Study start1 Feb 2015
Primary completion22 Jun 2016
Study completion22 Jun 2016

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 Technical University of MunichThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02307396
Sponsor's protocol ID: 1723/1-1
Other IDs: 2013-000338-37, DO 1723/1-1, DRKS00006878
Status last verified: Oct 2018
First submitted: 24 Nov 2014
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 1
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Healthy Adult Participants
Active, not recruiting
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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial
ClinicalTrials.gov ID: NCT02307396
Acronym / sponsor ID: 1723/1-1
Conditions: Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Technical University of MunichUniversity, hospital or other
Study start: 1 Feb 2015 (actual)
Primary completion: 22 Jun 2016 (actual)
Study completion: 22 Jun 2016 (actual)
First posted: 4 Dec 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Drug: Olanzapine, Drug: Amisulpride, Drug: Risperidone, Drug: Haloperidol, Drug: Quetiapine, Drug: Perphenazine, Drug: Sulpiride, Drug: bromperidol, Drug: Zuclopenthixol, Drug: Thioridazine, Drug: Paliperidone, Drug: Ziprasidone, Drug: Benperidol, Drug: Fluspirilene, Drug: Pimozide, Drug: Perazine, Drug: Fluphenazine, Drug: Flupentixole, Drug: SertindoleIntervention group: guided discontinuation or dose-reduction of the current antipsychotic medication. The antipsychotic drug used before study start will be discontinued gradually under medical surveillance. The process of discontinuation depends on the physicians judgement und should be guided be the participants needs and clinical status. This approach was already used before in another study ("gradual discontinuation", Wunderink et al., 2007). We assume that the dose can be reduced by approximately 1/6 of the starting dose every two weeks. If long acting antipsychotics are applied, there is no need for a gradual discontinuation due to their long half life.
Control	Active comparator	Drug: Olanzapine, Drug: Amisulpride, Drug: Risperidone, Drug: Haloperidol, Drug: Quetiapine, Drug: Perphenazine, Drug: Sulpiride, Drug: bromperidol, Drug: Zuclopenthixol, Drug: Thioridazine, Drug: Paliperidone, Drug: Ziprasidone, Drug: Benperidol, Drug: Fluspirilene, Drug: Pimozide, Drug: Perazine, Drug: Fluphenazine, Drug: Flupentixole, Drug: SertindoleThe participants receive the same antipsychotic drugs, they have received before the start of the study, without changing the dose or the application form. Study medication is, with exception of Clozapin, every oral or depot neuroleptic drug approved for the treatment of schizophrenia in Germany.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of schizophrenia or schizoaffective disorder
The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005) Score ≤3 for the items concerning psychosis of the "Positive and Negative Syndrom Scale" (PANSS; Kay et al., 1987): "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) and a score ≤3 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976)
Able to give informed consent

Key exclusion criteria (8 listed)

Actively suicidal
Serious medical illnesses
Known non-complience concerning the medication
Medication with clozapin
Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment

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
Olanzapine	Drug	Control, Intervention
Amisulpride	Drug	Control, Intervention
Risperidone	Drug	Control, Intervention
Haloperidol	Drug	Control, Intervention
Quetiapine	Drug	Control, Intervention
Perphenazine	Drug	Control, Intervention
Sulpiride	Drug	Control, Intervention
bromperidol	Drug	Control, Intervention
Zuclopenthixol	Drug	Control, Intervention
Thioridazine	Drug	Control, Intervention
Paliperidone	Drug	Control, Intervention
Ziprasidone	Drug	Control, Intervention
Benperidol	Drug	Control, Intervention
Fluspirilene	Drug	Control, Intervention
Pimozide	Drug	Control, Intervention
Perazine	Drug	Control, Intervention
Fluphenazine	Drug	Control, Intervention
Flupentixole	Drug	Control, Intervention
Sertindole	Drug	Control, Intervention

Primary outcome

Relapse
Time frame: Every 2 weeks up to 26 weeks
The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled: 1. Score ≥4 (moderate) for at least two of the following PANSS-items : "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) (PANSS; Kay et al., 1987) 2. Score ≥4 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976b)

11 secondary outcomes

Psychiatric rehospitalisation
Time frame: Every 2 weeks up to 26 weeks
Totalscore of Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, then every 4 weeks up to 26 weeks
Occurence of specific adverse effects (open interview)
Time frame: Baseline,then every 4 weeks up to 26 weeks
Clinical Global Impression - Severity Scale (CGI-S)
Time frame: Baseline, then every 4 weeks up to 26 weeks
"Quality of life" measured by the questionnaire "Subjective well-being under neuroleptics scale" (SW-N)
Time frame: Baseline, and after 12 and 26 weeks
Status of occupation
Time frame: Baseline, and after 12 and 26 weeks
Personal and Social Performance (Personal and Social Performance Scale [PSP])
Time frame: Baseline, and after 12 and 26 weeks
Adherence/Attitude of patients towards medication (Medication Adherence Rating Scale [MARS])
Time frame: Baseline, and after 12 and 26 weeks
Drop-outs total and due to specific reasons
Time frame: Every 2 weeks up to 26 weeks
Movement disorders (Abnormal Involuntary Movement Scale [AIMS])
Time frame: Baseline, and after 12 and 26 weeks
Weight change
Time frame: Baseline, and after 12 and 26 weeks

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 11 Oct 2018.

Related trials for Schizophrenia

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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.

Stefan Leucht, Professor principal investigator

Klinikum rechts der Isar

Markus Dold, MD principal investigator

Klinikum rechts der Isar

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 Oct 2018. 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 (time frame: Every 2 weeks up to 26 weeks). 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 NCT02307396.

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 11 Oct 2018.