SchizophreniaNCT01029769

Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia

A study testing Olanzapine or amisulpride in people with Schizophrenia and Schizoaffective Disorder, 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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
What is being tested?: Olanzapine or amisulpride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 1 siteGermany
Study dates: Dec 2009to Mar 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV TR) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
PANSS total score at baseline > 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)
Increase in the level of care (outpatient care to day clinic or inpatient care)

Who cannot join

contraindication to study drugs

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: The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment

The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic

Read the detailed description

The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.

Those participants who have not responded to treatment at two weeks (PANSS improvement <25%) will be randomised to a 6 week double blind flexible dose phase:

Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)
Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks

Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Being tested: Olanzapine or amisulpride
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.

Olanzapine or amisulprideDrug
Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding

Study groups in NCT01029769
Study group	Role	What they receive
initial olanzapine	Active comparator	Not described Receives: Drug: Olanzapine or amisulpride
initial amisulpride	Active comparator	Not described Receives: Drug: Olanzapine or amisulpride
early responders	Active comparator	Not described Receives: Drug: Olanzapine or amisulpride
early non-responders switched	Active comparator	Not described Receives: Drug: Olanzapine or amisulpride
ealy non-responders non-switched	Active comparator	Not described Receives: Drug: Olanzapine or amisulpride

What is being measured

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

Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders
Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is >3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating
Measured: 8 weeks

Secondary outcomes (1)

PANSS Total Score Change
The Positive and Negative Syndrome Scale (Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bull 1987; 13:261-276) is a 30- item inventory assessing the absence or severity of schizophrenia symptoms across three subscales: positive symptoms (items P1-P7, including hallucinatory behavior, delusions, and conceptual disorganization), negative symptoms (items N1-N7, including blunted affect, social and emotional withdrawal, and lack of spontaneity), and general psychopathology symptoms (items G1-G16, including mannerisms and posturing, unusual thought content, and lack of insight). Each item is scored on a scale ranging from 1 (absent) to 7 (extreme), with item ratings incorporating the presence, effects of symptoms on an individuum's thinking, feeling or behaving as well as their severity. The min. sum rating is 30, the max. sum rating is 210.
Measured: 8 weeks

Timeline

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

Dec 2009Mar 2015

First posted10 Dec 2009 (estimated)
Study startDec 2009
Primary completionMar 2014
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01029769
Sponsor's protocol ID: 01KG0910
Status last verified: May 2015
First submitted: 9 Dec 2009
Last updated: 21 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
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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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Switch Study - Efficacy of Early Antipsychotic Switch Versus Maintenance in Patients With Schizophrenia Poorly Responding to Two Weeks of Antipsychotic Treatment
ClinicalTrials.gov ID: NCT01029769
Acronym / sponsor ID: 01KG0910
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Technical University of MunichUniversity, hospital or other
Study start: Dec 2009
Primary completion: Mar 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 10 Dec 2009 (estimated)
Results: Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.

Those participants who have not responded to treatment at two weeks (PANSS improvement <25%) will be randomised to a 6 week double blind flexible dose phase:

Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)
Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
initial olanzapine	Active comparator	Drug: Olanzapine or amisulpride
initial amisulpride	Active comparator	Drug: Olanzapine or amisulpride
early responders	Active comparator	Drug: Olanzapine or amisulpride
early non-responders switched	Active comparator	Drug: Olanzapine or amisulpride
ealy non-responders non-switched	Active comparator	Drug: Olanzapine or amisulpride

Who may qualify

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

Key inclusion criteria (3 listed)

Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV TR) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
PANSS total score at baseline > 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)
Increase in the level of care (outpatient care to day clinic or inpatient care)

Key exclusion criteria (1 listed)

contraindication to study drugs

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 or amisulprideOral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding	Drug	ealy non-responders non-switched, early non-responders switched, early responders, initial amisulpride, initial olanzapine

Primary outcome

Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders
Time frame: 8 weeks
Remission is defined as a maximum rating of 3 points (equals a severity rating of "mild") in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is >3 the remission status is "no" (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating

1 secondary outcome

PANSS Total Score Change
Time frame: 8 weeks

Results and safety

Results posted to the registry on 21 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Olanzapin	163	140
Initial Amisulpride	164	145
Early Responders	0	0
Early Non-responders Switched	0	0
Ealy Non-responders Non-switched	0	0

Primary outcome: Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Early Non-responders Switched n = 60	Early Non-responders Non-switched n = 55
Value	41	25

Early Non-responders Switched vs Early Non-responders Non-switched: p =0.01, Regression, Logistic

Population analysed: please note that all patients, regardless of the medication received, were combined in these groups for the primary endpoint analysis solely depending on whether they have met the criteria for "early non-response" at the end of phase I of the trial; so the statistical analysis does not follow the treatment arms in phase I of the trial (patients received alternatively olanzapine or amisulpride, but both types of treatment appear in one and the same analysis group!)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Entire 8 weeks of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: Initital 2-week Treatment - Amisulpride Treated Patients	3 of 163 (1.8%)	36 of 163 (22.1%)	0 of 163
Period 1: Initital 2-week Treatment - Olanzapine Treated Patients	3 of 164 (1.8%)	33 of 164 (20.1%)	1 of 164
Period 2: Extended 6-week Treatment - Early Responders	7 of 140 (5%)	32 of 140 (22.9%)	1 of 140
Period 2: Extended 6-week Treatment - Early Non-responders Switched	5 of 70 (7.1%)	21 of 70 (30%)	0 of 70
Period 2: Extended 6-week Treatment - Early Non-responders Not Switched	4 of 72 (5.6%)	7 of 72 (9.7%)	0 of 72

Limitations and caveats (from the sponsor): Patients with poor response to antipsychotic treatment in the past (treatment resistant patients) were not excluded by definition from study participation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, MD principal investigator

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universität München am 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?

A study testing Olanzapine or amisulpride in people with Schizophrenia and Schizoaffective Disorder, run by Technical 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 1 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 21 Oct 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders (time frame: 8 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 NCT01029769.

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 21 Oct 2024.