ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000937011

Ethics application status

Not yet submitted

Date submitted

21/10/2010

Date registered

4/11/2010

Date last updated

4/03/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Prevention of Lowered Mood in Major Depressive Disorder with Quetiapine extended release after remission has been induced by electroconvulsive therapy (ECT)

Scientific title

PREQUEL study- Prevention after ECT with Quetiapine extended release of Lowered Mood (in remitted Major Depressive Disorder following ECT)

Secondary ID [1]

Not applicable

Universal Trial Number (UTN)

U1111-1117-5227

Trial acronym

PREQUEL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Major Depressive Disorder (MDD)

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a multicentre (St Vincent's Melbourne, The Melbourne Clinic and The Albert Road Clinic) clinical study of patients with a DSM-IV TR MDD, who have failed to respond to an adequate trial of at least one antidepressant (SSRI or SNRI) or when ECT is the preferred treatment.
Randomization will be into two parallel groups of 20 participants (outpatients and/or inpatients) each.
One group will be treated with Quetiapine XR (flexible dose of 50 to 300 mg daily orally, with dose changes determined by CGI-I scores and tolerability) in combination with TAU (SSRI/SNRI not previously prescribed) and the other group with TAU. TAU is determined by the treating clinician’s selection of monotherapy of a single antidepressant (SSRI/SNRI) at therapeutic dosage and not previously associated with failed response/poor tolerability. The dose range of Quetiapine XR will be flexibly adjusted from 50mg to 300 mg orally. Changes in study medication dose are made according to clinical response (continuation of the current dose if HAMD less than or equal to 7 and CGI-I less than or equal to 3 and increase in dose by 100 mg if HAMD > 7 and < 15 and CGI-I > 3) and tolerability (including as measured by SAS (Simpson and Angus, 1970) and LUNSERS (Day et al, 1995).The duration of treatment will be up to 6 months.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Treatment as usual-TAU (SSRI/SNRI not previously prescribed)

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure is the magnitude of depressive symptoms is measured by the Hamilton Depresion Rating Scale (HAMD) score.
The primary objective will also be assessed by the prevention of depressive relapse, measured by the HAMD. Depressive relapse is defined as HAMD greater than or equal to 15.

Timepoint [1]

Participants will be reviewed weekly for first month and monthly for 6 months in total. The total assessment time is 6 months.

Secondary outcome [1]

Clinical Global Impression (CGI-I)-Global Improvement Scale.

Timepoint [1]

Participants will be reviewed weekly for first month and monthly for 6 months in total. The total assessment time is 6 months.

Eligibility

Key inclusion criteria

*Provision of written informed consent prior to any study specific procedures
*A diagnosis of Major Depressive Disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text-Revision (DSM-IV TR)
*Males and females aged 18 to 65 years.
*HAMD less than or equal to 7 following a course of ECT which produces remission of depression (HAMD = 7) that is sustained over the last two ECT treatments in the course of ECT, after failure to respond to an adequate trial of at least one antidepressant medication (SSRI or SNRI) or when ECT is the preferred treatment.
* Completion of acute course of ECT within 3 weeks of baseline.
*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
*Able to understand and comply with the requirements of the study.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Any of the following is regarded as a criterion for exclusion from the study:
*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 and/or SSRI/SNRI , 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 3A4 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 randomisation/baseline
*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 or clinically relevant abnormal laboratory values) as judged by the investigator
*Involvement in the planning and conduct of the study
*Previous enrolment or randomisation of treatment in the present study.
*Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
*A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
a)Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
b)Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
c)Not under physician care for DM
d)Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled.
e)Physician responsible for patient’s DM care has not approved patient’s participation in the study
f)Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
g)Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
*An absolute neutrophil count (ANC) of less than or equal to 1.5 x 10 to the 9 per litre

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patient eligibility will be established before treatment randomisation. Patients will be randomised strictly sequentially, as patients are eligible for enrolment/randomisation. If a patient discontinues from the study, the patient number will not be reused, and the patient will not be allowed to re-enter the study.
This is an open-label study. The treatment allocation is based on random assignment of individual participants based on a computer-generated sequence. The randomization sequence/code will be concealed from all personnel, but the treatment thereafter will not.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Date of first participant enrolment

Anticipated

1/03/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

AstraZeneca

Address [1]

5 Alma Road, North Ryde NSW 2113

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital

Address

46 Nicholson St
Fitzroy, 3065, Melbourne, Vic.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St Vincent's Hospital, Melbourne

Ethics committee address [1]

PO Box 2900, Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2010

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

There is emerging that the medication, Quetiapine (trade name: Seroquel) is clinically useful in treating clinically significant depression (major depressive disorder) and in the augmentation of antidepressant medication in this condition and depression that occurs in bipolar disorder (manic-depression). Quetiapine is currently approved for  the treatment of schizophrenia and bipolar disorder.

This study will look at whether the addition of the medication Quetiapine XR (trade name: Seroquel XR) to standard antidepressant medication is better than antidepressant medication alone in keeping symptoms of depression to a minimum after a clinically beneficial course of electroconvulsive therapy (ECT) within the previous 3 weeks for clinical depression (major depressive disorder). Participation in the study will occur after remission (disappearance) of clinically significant depression has occurred after treatment with ECT, when there has been failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment.

People will be invited to participate in the study if they: are aged 18-65 years ;have
been diagnosed as experiencing major depressive disorder; have had a course of ECT
completed within the previous 3 weeks, which has led to remission of depression
sustained over the last 2 ECT treatments of the ECT course, after failure to respond   to
an adequate trial of at least one antidepressant medication, or when ECT is the
preferred treatment.  People will not be able to participate in the study if they are: at
immediate risk to themselves or others;  dependent on  alcohol or other substances,
apart from caffeine or nicotine; or have diabetes mellitus that is not stable or well
controlled.  Women who are pregnant, or may become pregnant, or are lactating
during the course of the study, will also  not be able to participate in the study.

There will be 2 groups of 20 participants, each, in the study. One group will be treated with the medication Quetiapine XR in combination with an antidepressant medication. Another group will be treated with an antidepressant medication alone. The antidepressant medications, either a selective serotonin reuptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) that has not been previously prescribed, or previously not helpful in preventing relapse of clinically significant depression, will be prescribed by treating doctors. The addition of Quetiapine XR to the antidepressant medication will be randomly determined, so that the study doctors or treating doctors will have no prior knowledge nor influence on whether this medication is added to prescribed antidepressant medication. The dose of Quetiapine XR will range from 50 milligrams to a maximum of 300 milligrams per day, with doses adjusted according to clinical response to, and tolerability of this medication. Psychiatric medications other than the prescribed antidepressant medication or Quetiapine XR, will not be prescribed or permitted during the course of the study. 

The duration of the study is 6 months, with weekly study visits for the first month and monthly, thereafter for the remaining 5 months. Participants will be asked questions about the presence of depressive symptoms and how they are tolerating their medication, as well as a physical examination as part of each study visit. Participants will have blood tests (clinical chemistry, haematology) prior to commencing the study, and at 1,2,3 and 6 months.  Participants will also have a fasting (not having eaten, or drunk anything other than water since midnight) prior to commencing the study, and at 3 and 6 months. Participants will also have a urine drug test and electrocardiogram (ECG) prior to commencement. Participants will be free to withdraw their consent at any stage without affecting or prejudicing their clinical care in any way.  In the event of depressive relapse (recurrence of clinically significant depression), participants will be discontinued from study, with alternative treatment arrangements made in consultation with their primary treating medical practitioner.

Trial website

Not applicable

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof A/Prof Peter Bosanac

Address

This has not changed

Country

Australia

Phone

+61392884329

Fax

peter.bosanac@svhm.org.au

Contact person for public queries

Name

Dr Peter Bosanac

Address

46 Nicholson St, Fitzroy 3065, Melbourne, Vic.

Country

Australia

Phone

+61392884329

Fax

peter.bosanac@svhm.org.au

Contact person for scientific queries

Name

Dr Peter Bosanac

Address

46 Nicholson St, Fitzroy 3065, Melbourne, Vic.

Country

Australia

Phone

+61392884329

Fax

peter.bosanac@svhm.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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