SchizophreniaPhase 3NCT01672554
Clinical Benefits of Seroquel XR in Anxiety Disorder
A Phase 3 study testing Quetiapine XR in people with Schizophrenia and Anxiety, run by Corporation de Recherche en Neuropsycho Pharmacologie de Quebec at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Anxiety
- What is being tested?
- Quetiapine XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Schizophrenia, Anxiety
- Being tested
- Quetiapine XR
- Keywords
- Schizophrenia, Anxiety disorder
- Medical subject headings
- Schizophrenia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine XRDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Seroquel XR | Other | 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. Receives: Drug: Quetiapine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: Evaluated at each visit over 6 months: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startDec 2008
- Primary completionApr 2012
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporation de Recherche en Neuropsycho Pharmacologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roch-Hugo Bouchard, MD, FRCPC, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672554
- Sponsor's protocol ID
- D1443C00030
- Status last verified
- Aug 2012
- First submitted
- 20 Aug 2012
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01672554
- Acronym / sponsor ID
- D1443C00030
- Conditions
- Schizophrenia, Anxiety
- Keywords
- Schizophrenia, Anxiety disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Corporation de Recherche en Neuropsycho Pharmacologie de QuebecUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seroquel XR | Other | Drug: Quetiapine XRQuetiapine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine XRQuetiapine 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. | Drug | Seroquel XR |
Primary outcome
Anxiety disorder
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.
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.
1 secondary outcome
Tolerability and safety
Time frame: Evaluated at each visit over 6 months: day 1, day 7, day 14, month 1, month 2, month 3 and month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roch-Hugo Bouchard, MD, FRCPC principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine XR in people with Schizophrenia and Anxiety, run by Corporation de Recherche en Neuropsycho Pharmacologie de Quebec at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety disorder (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.