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Psychotic DisordersPhase 4BPPNCT00932529

Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

A Phase 4 study testing Olanzapine, Quetiapine and Risperidone in people with Psychotic Disorders, run by University of Bergen at 1 site in Norway.

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

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychotic Disorders
What is being tested?
Olanzapine, Quetiapine and Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteNorway
Study dates
Feb 2003to Jan 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Psychosis
  • Must be able to use oral antipsychotic drugs

Who cannot join

  • Mania
  • Unable to cooperate with the assessments
  • Unable to understand Norwegian language
  • Candidates for electroconvulsive therapy
  • Use of Clozapine at admittance

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital, Division of Psychiatry

    Bergen, Sandviken, N-5035

Other trials in Norway

About this study

Official title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.

Being tested
Olanzapine, Quetiapine, Risperidone, Ziprasidone
Keywords
Antipsychotic drugs, Treatment effectiveness, Randomized controlled trial
Medical subject headings
Psychotic Disorders

What participants receive

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

  • OlanzapineDrug

    Also called Zyprexa

    Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion

  • QuetiapineDrug

    Also called Seroquel

    Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.

  • RisperidoneDrug

    Also called Risperdal

    Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.

  • ZiprasidoneDrug

    Also called Zeldox, Geodon

    Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion

Study groups in NCT00932529
Study groupRoleWhat they receive
OlanzapineActive comparatorNot described
Receives: Drug: Olanzapine; Drug: Quetiapine; Drug: Ziprasidone
QuetiapineActive comparatorNot described
Receives: Drug: Olanzapine; Drug: Risperidone; Drug: Ziprasidone
RisperidoneActive comparatorNot described
Receives: Drug: Olanzapine; Drug: Ziprasidone
ZiprasidoneActive comparatorNot described
Receives: Drug: Olanzapine; Drug: Ziprasidone

What is being measured

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

  1. Reduction of PANSS total score

    Measured: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.

Secondary outcomes (2)

  1. Tolerability

    Measured: Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge

  2. Time until initial drug discontinuation

    Measured: Up to 24 months follow-up

Timeline

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

  1. First posted3 Jul 2009 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

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
Investigator
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00932529
Sponsor's protocol ID
NSD-ID10591
Acronym
BPP
Status last verified
Dec 2003
First submitted
2 Jul 2009
Last updated
25 May 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Bjarke J, Sinkeviciute I, Kroken RA, Loberg EM, Jorgensen HA, Johnsen E, Gjestad R. Different response patterns in hallucinations and delusions to antipsychotic treatment. Nord J Psychiatry. 2020 Oct;74(7):497-504. doi: 10.1080/08039488.2020.1745273. Epub 2020 Apr 3.

    PubMed 32242498

  • Kjelby E, Gjestad R, Sinkeviciute I, Kroken RA, Loberg EM, Jorgensen HA, Johnsen E. Trajectories of depressive symptoms in the acute phase of psychosis: Implications for treatment. J Psychiatr Res. 2018 Aug;103:219-228. doi: 10.1016/j.jpsychires.2018.06.003. Epub 2018 Jun 2.

    PubMed 29890508

  • Johnsen E, Fathian F, Kroken RA, Steen VM, Jorgensen HA, Gjestad R, Loberg EM. The serum level of C-reactive protein (CRP) is associated with cognitive performance in acute phase psychosis. BMC Psychiatry. 2016 Mar 14;16:60. doi: 10.1186/s12888-016-0769-x.

    PubMed 26973142

  • Kjelby E, Sinkeviciute I, Gjestad R, Kroken RA, Loberg EM, Jorgensen HA, Hugdahl K, Johnsen E. Suicidality in schizophrenia spectrum disorders: the relationship to hallucinations and persecutory delusions. Eur Psychiatry. 2015 Oct;30(7):830-6. doi: 10.1016/j.eurpsy.2015.07.003. Epub 2015 Sep 25.

    PubMed 26443050

  • Johnsen E, Aanesen K, Sriskandarajah S, Kroken RA, Loberg EM, Jorgensen HA. QTc Prolongation in Patients Acutely Admitted to Hospital for Psychosis and Treated with Second Generation Antipsychotics. Schizophr Res Treatment. 2013;2013:375020. doi: 10.1155/2013/375020. Epub 2013 Dec 31.

    PubMed 24490070

  • Johnsen E, Sinkeviciute I, Loberg EM, Kroken RA, Hugdahl K, Jorgensen HA. Hallucinations in acutely admitted patients with psychosis, and effectiveness of risperidone, olanzapine, quetiapine, and ziprasidone: a pragmatic, randomized study. BMC Psychiatry. 2013 Sep 30;13:241. doi: 10.1186/1471-244X-13-241.

    PubMed 24079855

  • Kjelby E, Jorgensen HA, Kroken RA, Loberg EM, Johnsen E. Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial. BMC Psychiatry. 2011 Aug 31;11:145. doi: 10.1186/1471-244X-11-145.

    PubMed 21884578

  • Johnsen E, Gjestad R, Kroken RA, Mellesdal L, Loberg EM, Jorgensen HA. Cardiovascular risk in patients admitted for psychosis compared with findings from a population-based study. Nord J Psychiatry. 2011 Jun;65(3):192-202. doi: 10.3109/08039488.2010.522729. Epub 2010 Sep 29.

    PubMed 20879830

  • Johnsen E, Kroken RA, Wentzel-Larsen T, Jorgensen HA. Effectiveness of second-generation antipsychotics: a naturalistic, randomized comparison of olanzapine, quetiapine, risperidone, and ziprasidone. BMC Psychiatry. 2010 Mar 24;10:26. doi: 10.1186/1471-244X-10-26.

    PubMed 20334680

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olanzapine, Quetiapine and Risperidone in people with Psychotic Disorders, run by University of Bergen at 1 site in Norway.

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 2 inclusion and 5 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 25 May 2010. 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 Norway. 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?

Reduction of PANSS total score (time frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.). 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 NCT00932529, which also lists 9 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 25 May 2010.

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