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Clinical Benefits of Seroquel XR in Anxiety Disorder

Primary Purpose

Schizophrenia, Anxiety

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine XR
Sponsored by
Corporation de Recherche en Neuropsycho Pharmacologie de Quebec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Anxiety disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of written informed consent;
  • A diagnosis of schizophrenia or schizophrenia spectrum psychosis (schizophreniform, schizoaffective, delusional disorder, brief psychosis) as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV);
  • Presenting a co-morbid anxiety disorder not well controlled with the current pharmacological treatment according to the investigator corresponding to DSM-IV;
  • Having an initial score of more than 20 at enrolment on HAM-A scale;
  • Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment;

Exclusion Criteria:

  • Patient with an antidepressant or benzodiazepine recently (last 4 weeks) introduced, or that had requested a dosing adjustment in the last 4 weeks;
  • Patient with an anticholinergic taken on a regular basis;
  • Patient receiving more than one antipsychotic;
  • Pregnancy or lactation;
  • Any DSM-IV Axis I disorder not defined in the inclusion criteria;
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others;
  • Known intolerance or lack of response to Quetiapine fumarate, as judged by the investigator;
  • Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir;
  • Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids;
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment;
  • Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria;
  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment;
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
  • Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator;
  • Involvement in the planning and conduct of the study;
  • Previous enrolment of treatment in the present study;
  • Participation in a phase I-II-III drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements;
  • A patient with Diabetes Mellitus (DM) - An absolute neutrophil count (ANC) of 1.5 x 109 per liter;
  • An ALT-AST count of 3 x ULN and/or Bilirubin count 1.5 x ULN;
  • Any clinically significant laboratory abnormality, as judged by the investigator.

Sites / Locations

  • CRNPQ

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Seroquel XR

Arm Description

Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.

Outcomes

Primary Outcome Measures

Anxiety disorder
Our main objective will be to assess over 6 months, the impact of a switch to Seroquel XR in subjects suffering from schizophrenia associated with a co morbid anxiety disorder as measured by well-validated clinical anxiety scales.

Secondary Outcome Measures

Tolerability and safety
To assess tolerability and safety profile after a switch to Seroquel XR in such population over 6 months. To do so a pharmacological evaluation will collected, this includes spontaneous patient self-report of any adverse event. The UKU (Udvalg for klinedke Undersodgelser)side effect rating scale will also address drug side effects. The patient perception of medication will be assessed by the Drug Attitude Inventory (DAI) scale and will be used as a compliance indicator. Extrapyramidal Symptom Rating Scale (ESRS) will be performed to assess extrapyramidal side effects. Current concomitant medication will be recorded also.

Full Information

First Posted
August 20, 2012
Last Updated
August 22, 2012
Sponsor
Corporation de Recherche en Neuropsycho Pharmacologie de Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT01672554
Brief Title
Clinical Benefits of Seroquel XR in Anxiety Disorder
Official Title
Open Label, Non-randomised, Single Arm, Phase IIIB Switch Study: Evaluating the Clinical Benefits of Quetiapine XR in Patients With Schizophrenia and Anxiety Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporation de Recherche en Neuropsycho Pharmacologie de Quebec

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research will explore whether Quetiapine XR used primarily to treat psychosis may also cover for comorbid anxiety disorder and offer advantages in patients with schizophrenia and comorboid anxiety disorder. Preliminary data on pharmacological properties of Quetiapine and its metabolites and intuitive impression from our clinical experience lead to believe that Seroquel XR use in monotherapy may offer advantages over other antipsychotics in treating co-morbid anxiety disorder in patients suffering from schizophrenia. This open label switch study conducted in a schizophrenic population intends to verify this hypothesis.
Detailed Description
This is an open label, non-randomised, single arm phase IIIB study. Patients will be enrolled in this study if their current antipsychotic medication does not provide optimal control of psychopathology symptoms, as judged by the investigator. Therefore, the patients will not be switched from their current effective and well tolerated antipsychotic regimen to the study drug for the sole reason of being enrolled into the study. After enrolment, patients will be switched to Quetiapine XR and followed in an intent-to-treat design over 6 months. Even if a patient should stop for any reason Quetiapine XR or require adding or adjusting an antidepressant for anxiety resistant symptoms, he/she will be assessed for the entire study. Data will be analysed separately. Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Anxiety
Keywords
Schizophrenia, Anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seroquel XR
Arm Type
Other
Arm Description
Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Intervention Description
Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.
Primary Outcome Measure Information:
Title
Anxiety disorder
Description
Our main objective will be to assess over 6 months, the impact of a switch to Seroquel XR in subjects suffering from schizophrenia associated with a co morbid anxiety disorder as measured by well-validated clinical anxiety scales.
Time Frame
Clinical anxiety scales will be assessed over 6 months at the following visits: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Secondary Outcome Measure Information:
Title
Tolerability and safety
Description
To assess tolerability and safety profile after a switch to Seroquel XR in such population over 6 months. To do so a pharmacological evaluation will collected, this includes spontaneous patient self-report of any adverse event. The UKU (Udvalg for klinedke Undersodgelser)side effect rating scale will also address drug side effects. The patient perception of medication will be assessed by the Drug Attitude Inventory (DAI) scale and will be used as a compliance indicator. Extrapyramidal Symptom Rating Scale (ESRS) will be performed to assess extrapyramidal side effects. Current concomitant medication will be recorded also.
Time Frame
Evaluated at each visit over 6 months: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Other Pre-specified Outcome Measures:
Title
Cognition
Description
To assess cognitive performance after a switch to Seroquel XR in such population over 6 months
Time Frame
The Matrics consensus battery will be performed at the baseline visit and at the end of study visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent; A diagnosis of schizophrenia or schizophrenia spectrum psychosis (schizophreniform, schizoaffective, delusional disorder, brief psychosis) as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); Presenting a co-morbid anxiety disorder not well controlled with the current pharmacological treatment according to the investigator corresponding to DSM-IV; Having an initial score of more than 20 at enrolment on HAM-A scale; Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment; Exclusion Criteria: Patient with an antidepressant or benzodiazepine recently (last 4 weeks) introduced, or that had requested a dosing adjustment in the last 4 weeks; Patient with an anticholinergic taken on a regular basis; Patient receiving more than one antipsychotic; Pregnancy or lactation; Any DSM-IV Axis I disorder not defined in the inclusion criteria; Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others; Known intolerance or lack of response to Quetiapine fumarate, as judged by the investigator; Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir; Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids; Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment; Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria; Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment; Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment; Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator; Involvement in the planning and conduct of the study; Previous enrolment of treatment in the present study; Participation in a phase I-II-III drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements; A patient with Diabetes Mellitus (DM) - An absolute neutrophil count (ANC) of 1.5 x 109 per liter; An ALT-AST count of 3 x ULN and/or Bilirubin count 1.5 x ULN; Any clinically significant laboratory abnormality, as judged by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roch-Hugo Bouchard, MD, FRCPC
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRNPQ
City
Quebec
ZIP/Postal Code
G1R2W8
Country
Canada

12. IPD Sharing Statement

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Clinical Benefits of Seroquel XR in Anxiety Disorder

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