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Use, Effects and Side-Effects of Second-Generation Antipsychotics in a Naturalistic Setting (BPP)
This study is ongoing, but not recruiting participants.
First Received: July 2, 2009   No Changes Posted
Sponsored by: University of Bergen
Information provided by: University of Bergen
ClinicalTrials.gov Identifier: NCT00932529
  Purpose

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.


Condition Intervention Phase
Psychotic Disorders
Drug: Olanzapine
Drug: Quetiapine
Drug: Risperidone
Drug: Ziprasidone
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Use, Effects and Side-Effects of Second-Generation Antipsychotics in a Naturalistic Setting.

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Reduction of PANSS total score [ Time Frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge ] [ Designated as safety issue: Yes ]
  • Time until initial drug discontinuation [ Time Frame: Up to 24 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 226
Study Start Date: February 2003
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Olanzapine: Active Comparator Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Quetiapine
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Quetiapine: Active Comparator Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Risperidone
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Risperidone: Active Comparator Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Ziprasidone: Active Comparator Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932529

Locations
Norway, Sandviken
Haukeland University Hospital, Division of Psychiatry
Bergen, Sandviken, Norway, N-5035
Sponsors and Collaborators
University of Bergen
  More Information

No publications provided

Responsible Party: University of Bergen ( Hugo A. Jørgensen )
Study ID Numbers: NSD-ID10591
Study First Received: July 2, 2009
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00932529     History of Changes
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Bergen:
Antipsychotic drugs
Treatment effectiveness
Randomized controlled trial

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Risperidone
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Schizophrenia
Quetiapine
Dopamine
Mental Disorders
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Quetiapine
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Ziprasidone
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009