Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia

NCT01213836 | Completed Phase 4 Results

• 2 other identifiers: D1443L000822010-020579-21
• Study Type: interventional
• Target: 75
• Locations: 5 countries
• Sites: 20

Brief Summary

This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication.

Conditions

Schizophrenia

Keywords

Stable schizophrenia; cognitive functioning

Outcome Measures

Primary Outcomes (1)

• Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)

  Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.

  Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

Secondary Outcomes (6)

• Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)

  Before taking study drug, end of Period 1 and end of Period 2

• Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving

  Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

• Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label

  Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

• Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label

  Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

• Number of Dropouts.

  Period 1 and Period 2

Study Arms (2)

First Seroquel XR then Seroquel IR

ACTIVE COMPARATOR

Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days

Drug: Seroquel XR- quetiapine fumarate extended release; Drug: Seroquel IR - quetiapine fumarate; Drug: Placebo matching Seroquel XR; Drug: Placebo matching Seroquel IR

First Seroquel IR then Seroquel XR

ACTIVE COMPARATOR

Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days

Drug: Seroquel XR- quetiapine fumarate extended release; Drug: Seroquel IR - quetiapine fumarate; Drug: Placebo matching Seroquel XR; Drug: Placebo matching Seroquel IR

Interventions

Seroquel XR- quetiapine fumarate extended release DRUG

Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.

First Seroquel IR then Seroquel XR; First Seroquel XR then Seroquel IR

Seroquel IR - quetiapine fumarate DRUG

Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.

First Seroquel IR then Seroquel XR; First Seroquel XR then Seroquel IR

Placebo matching Seroquel XR DRUG

Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.

First Seroquel IR then Seroquel XR; First Seroquel XR then Seroquel IR

Placebo matching Seroquel IR DRUG

Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

First Seroquel IR then Seroquel XR; First Seroquel XR then Seroquel IR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent prior to any study specific procedures
• Documented clinical diagnosis of schizophrenia, paranoid type, for at least 2 years before randomisation meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.3) confirmed by MINI version 5.0
• Outpatient status at enrolment
• Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation

You may not qualify if:

• Previous stable use of high dosage of benzodiazepines during one year or more
• Significant neurological medical history (complicated head trauma as judged by the investigator, epilepsy, meningo-encephalitis)
• Use of the following medication:
• other antipsychotic drug than quetiapine within 28 days prior to randomisation
• a depot antipsychotic injection within two dosing intervals (for the depot) before randomisation (Visit 2)
• other psychoactive drugs within 14 days prior to randomisation (hypnotic or anxiolytic drugs, other than those allowed)
• Use of concomitant therapy likely to affect cognition, Medication prohibited 28 days prior to randomisation: benzodiazepines, amphetamines, reboxitin, atomoxinetine, buspiron, donepezil, duloxetine, galantamine, ginko biloba, memantine, methylphenidate, modafinil, rivastigmine, tacrine, smoking cessation therapy varencicline and any dosage form of nicotine replacement therapy. Medication prohibited 14 days prior to randomisation: irreversible monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), biperiden, antoicholinergic agents (even if the indications are extra pyramidal symptoms or urinary symptoms)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

Vienna, Austria

Location

Research Site

Middelfart, Denmark

Location

Research Site

Berlin, Germany

Location

Research Site

Bochum, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

München, Germany

Location

Research Site

Rottweil, Germany

Location

Research Site

Giarre, CT, Italy

Location

Research Site

Genova, GE, Italy

Location

Research Site

Lido di Camaiore, LU, Italy

Location

Research Site

Barakaldo (vizcaya), Pais Vasco, Italy

Location

Research Site

Tivoli, RM, Italy

Location

Research Site

Sant'Arsenio, SA, Italy

Location

Research Site

Sassari, SS, Italy

Location

Research Site

Borgomanero, Italy

Location

Research Site

Catania, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Torre Annunziata, Italy

Location

Research Site

Salamanca, Castille and León, Spain

Location

Research Site

Zamora, Castille and León, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Gerard Lynch
• Organization: Astra Zeneca

ClinicalTrailTransparency@astrazeneca.com

Study Officials

• Eva Dencker Vansvik

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-05

Locations

DK (1); AU (1); IT (11); ES (2); DE (5)