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

NCT00932529 | Completed Phase 4 DMC

• 1 other identifier: NSD-ID10591
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psychotic Disorders

Keywords

Antipsychotic drugs; Treatment effectiveness; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Reduction of PANSS total score

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

Secondary Outcomes (2)

• Tolerability

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

• Time until initial drug discontinuation

  Up to 24 months follow-up

Study Arms (4)

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine; Drug: Quetiapine; Drug: Ziprasidone

Quetiapine

ACTIVE COMPARATOR

Drug: Olanzapine; Drug: Risperidone; Drug: Ziprasidone

Risperidone

ACTIVE COMPARATOR

Drug: Olanzapine; Drug: Ziprasidone

Ziprasidone

ACTIVE COMPARATOR

Drug: Olanzapine; Drug: Ziprasidone

Interventions

Olanzapine DRUG

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

Also known as: Zyprexa

Olanzapine; Quetiapine; Risperidone; Ziprasidone

Quetiapine DRUG

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

Also known as: Seroquel

Olanzapine

Risperidone DRUG

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

Also known as: Risperdal

Quetiapine

Ziprasidone DRUG

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

Also known as: Zeldox, Geodon

Olanzapine; Quetiapine; Risperidone; Ziprasidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychosis
• Must be able to use oral antipsychotic drugs

You may not qualify if:

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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

Haukeland University Hospital, Division of Psychiatry

Bergen, Sandviken, N-5035, Norway

Location

Related Publications (9)

• 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.

  PMID: 32242498 DERIVED

• 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.

  PMID: 29890508 DERIVED

• 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.

  PMID: 26973142 DERIVED

• 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.

  PMID: 26443050 DERIVED

• 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.

  PMID: 24490070 DERIVED

• 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.

  PMID: 24079855 DERIVED

• 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.

  PMID: 21884578 DERIVED

• 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.

  PMID: 20879830 DERIVED

• 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.

  PMID: 20334680 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Olanzapine; Quetiapine Fumarate; Risperidone; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: February 1, 2003
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 25, 2010

Record last verified: 2003-12

Locations

NO (1)