search
Back to results

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

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Olanzapine
Quetiapine
Risperidone
Ziprasidone
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Antipsychotic drugs, Treatment effectiveness, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital, Division of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Olanzapine

Quetiapine

Risperidone

Ziprasidone

Arm Description

Outcomes

Primary Outcome Measures

Reduction of PANSS total score

Secondary Outcome Measures

Tolerability
Time until initial drug discontinuation

Full Information

First Posted
July 2, 2009
Last Updated
May 24, 2010
Sponsor
University of Bergen
search

1. Study Identification

Unique Protocol Identification Number
NCT00932529
Brief Title
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting
Acronym
BPP
Official Title
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bergen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Antipsychotic drugs, Treatment effectiveness, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Title
Quetiapine
Arm Type
Active Comparator
Arm Title
Risperidone
Arm Type
Active Comparator
Arm Title
Ziprasidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Zeldox, Geodon
Intervention Description
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Primary Outcome Measure Information:
Title
Reduction of PANSS total score
Time Frame
Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.
Secondary Outcome Measure Information:
Title
Tolerability
Time Frame
Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge
Title
Time until initial drug discontinuation
Time Frame
Up to 24 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Haukeland University Hospital, Division of Psychiatry
City
Bergen
State/Province
Sandviken
ZIP/Postal Code
N-5035
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32242498
Citation
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.
Results Reference
derived
PubMed Identifier
29890508
Citation
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.
Results Reference
derived
PubMed Identifier
26973142
Citation
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.
Results Reference
derived
PubMed Identifier
26443050
Citation
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.
Results Reference
derived
PubMed Identifier
24490070
Citation
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.
Results Reference
derived
PubMed Identifier
24079855
Citation
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.
Results Reference
derived
PubMed Identifier
21884578
Citation
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.
Results Reference
derived
PubMed Identifier
20879830
Citation
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.
Results Reference
derived
PubMed Identifier
20334680
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs