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

NCT ID: NCT00932529

Last Updated: 2010-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychotic Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olanzapine

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

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

Quetiapine

Intervention Type DRUG

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

Ziprasidone

Intervention Type DRUG

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

Quetiapine

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

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

Risperidone

Intervention Type DRUG

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

Ziprasidone

Intervention Type DRUG

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

Risperidone

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

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

Ziprasidone

Intervention Type DRUG

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

Ziprasidone

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

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

Ziprasidone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olanzapine

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

Intervention Type DRUG

Quetiapine

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

Intervention Type DRUG

Risperidone

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

Intervention Type DRUG

Ziprasidone

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zyprexa Seroquel Risperdal Zeldox, Geodon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Psychosis
* Must be able to use oral antipsychotic drugs

Exclusion Criteria

* Mania
* Unable to cooperate with the assessments
* Unable to understand Norwegian language
* Candidates for electroconvulsive therapy
* Use of Clozapine at admittance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Bergen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haukeland University Hospital, Division of Psychiatry

Bergen, Sandviken, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32242498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29890508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26973142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26443050 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24490070 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24079855 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21884578 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20879830 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20334680 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NSD-ID10591

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhancing Recovery in Early Schizophrenia
NCT02926859 RECRUITING PHASE2