An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

NCT01498770 | Completed

• 2 other identifiers: P08308MK-8274-108
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (8)

• Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater

  From baseline through 730 days after date of prescription

• Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder

  From baseline through 730 days after date of prescription

• Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis

  From baseline through 730 days after date of prescription

• Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK

  Baseline observation period (minimum of at least 365 days prior to date of prescription)

• Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK

  Baseline observation period (minimum of at least 365 days prior to date of prescription)

• Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis

  From baseline through 365 days after date of prescription

• Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK

  Baseline observation period (minimum of at least 365 days prior to date of prescription)

• Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK

  Baseline observation period (minimum of at least 365 days prior to date of prescription)

Study Arms (13)

Asenapine

Drug: Asenapine

Aripiprazole

Drug: Aripiprazole

Quetiapine

Drug: Quetiapine

Risperidone

Drug: Risperidone

Olanzapine

Drug: Olanzapine

Ziprasidone

Drug: Ziprasidone

Iloperidone

Drug: Iloperidone

Paliperidone

Drug: Paliperidone

Lurasidone

Drug: Lurasidone

Clozapine

Drug: Clozapine

Amisulpride

Drug: Amisulpride

Sertindole

Drug: Sertindole

Zotepine

Drug: Zotepine

Interventions

Asenapine DRUG

Asenapine prescribed as recorded in the CPRD in the UK

Also known as: Sycrest, SCH 900274

Asenapine

Aripiprazole DRUG

Aripiprazole prescribed as recorded in the CPRD in the UK

Also known as: Abilfy

Aripiprazole

Quetiapine DRUG

Quetiapine prescribed as recorded in the CPRD in the UK

Also known as: Seroquel

Quetiapine

Risperidone DRUG

Risperidone prescribed as recorded in the CPRD in the UK

Also known as: Risperdal

Risperidone

Olanzapine DRUG

Olanzapine prescribed as recorded in the CPRD in the UK

Also known as: Zyprexa

Olanzapine

Ziprasidone DRUG

Ziprasidone prescribed as recorded in the CPRD in the UK

Ziprasidone

Iloperidone DRUG

Iloperidone prescribed as recorded in the CPRD in the UK

Iloperidone

Paliperidone DRUG

Paliperidone prescribed as recorded in the CPRD in the UK

Paliperidone

Lurasidone DRUG

Lurasidone prescribed as recorded in the CPRD in the UK

Lurasidone

Clozapine DRUG

Clozapine prescribed as recorded in the CPRD in the UK

Clozapine

Amisulpride DRUG

Amisulpride prescribed as recorded in the CPRD in the UK

Amisulpride

Sertindole DRUG

Sertindole prescribed as recorded in the CPRD in the UK

Sertindole

Zotepine DRUG

Zotepine prescribed as recorded in the CPRD in the UK

Zotepine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is drawn from UK general practitioner practices participating in CPRD. The database is generally representative of the UK general population.

You may qualify if:

• At least 1 prescription for asenapine within the study period
• Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
• A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine
• Age 18 years or greater at the time participant receives a prescription for the comparator
• At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period
• Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
• A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine; Aripiprazole; Quetiapine Fumarate; Risperidone; Olanzapine; ziprasidone; iloperidone; Paliperidone Palmitate; Lurasidone Hydrochloride; Clozapine; Amisulpride; sertindole; zotepine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Pyrimidinones; Pyrimidines; Benzodiazepines; Benzazepines; Isoxazoles; Azoles; Thiazoles; Isoindoles; Dibenzazepines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: April 1, 2013
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: February 4, 2022

Record last verified: 2022-02