Major Depressive DisorderNCT00688818

Quetiapine in Co-Morbid Depressive and Anxiety Disorders

A study testing Quetiapine in people with Major Depressive Disorder and Dysthymic Disorder, run by Centre for Addiction and Mental Health at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This multi-centred study will be conducted at three centres. The design will be a randomized, placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria for depressive disorders and one or more… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder, Dysthymic Disorder, Anxiety Disorders
What is being tested?: Quetiapine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 4 sitesCanada
Study dates: Jun 2008to Jun 2013
Phase: Interventional
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
Male and female patients must be of 18 to 65 years of age.
Women of childbearing potential must have a negative pregnancy test and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study.
A diagnosis of Major Depressive Disorder or Dysthymic Disorder as defined by DSM-IV criteria and failed to respond to at least one first line treatment. The patient must be receiving antidepressant treatment (SSRIs, SNRIs or mirtazapine).
A co-morbid diagnosis of one or more of the following: Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, and Post Traumatic Stress Disorder, and Obsessive-Compulsive Disorder, as defined by DSM-IV criteria
A minimum score of ≥17 at Baseline on the 17-item HAM-D.
Able to understand and comply with the requirements of the study

Who cannot join

The presence or history of Psychotic Disorders, Bipolar Disorders, Mood Disorders with Psychotic Features
Patients who, in the investigator's judgment, would require treatment with additional psychotherapeutic drugs, electroconvulsive therapy (ECT), or intensive psychotherapy during the course of the study.
ECT within the preceding 6 months of screening before inclusion.
Regular, formal psychotherapy (excluding supportive therapy) started within the last 3 months before inclusion.
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.

Show all 21Show fewer

Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment
Use of any of the following significant cytochrome P450 inducers in the 14 days preceding enrolment
Patients who are currently receiving: monoamine oxidase inhibitors, tricyclic antidepressants, oral neuroleptics, or type 1C anti-arrhythmics within two weeks of screening; herbal psychoactive treatments (St. John's Wort, Kava Kava, Gingko Biloba) within two weeks of screening.
Patients taking SSRIs or SNRIs for less than two weeks or at a less than therapeutic dose prior to enrolment.
Patients who require concurrent psychotropic medication other than allowed medication specified in protocol.
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation.
Patients who have met DSM-IV criteria for abuse of or dependence on any drug, including alcohol within 3 months prior to screening.
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
Patients with clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit.
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 (HbA1c) >8.5%, b) hospital admission for 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 approved patient's participation in the study,or indicated DM is controlled e)change in dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period will 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 <= 1.5 x 10^9 per

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

Chatham-Kent Health Alliance
Chatham, Ontario, N7L1B7
Centre for Neuropsychiatric Study
Markham, Ontario, L6B 1A1
Credit Valley Medical Arts Centre
Mississauga, Ontario, L5M 4N4
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders

Read the detailed description

The primary objective is to examine the beneficial effect of quetiapine augmentation of first-line antidepressants in refractory depression with co-morbid anxiety, compared to placebo. It is hypothesized that significant improvement on depression and anxiety symptoms will be seen as evidenced by reduction in Hamilton Depression Rating Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) scores after the 12 week treatment period for those who received Quetiapine XR augmentation compared to those who received placebo.2.2

Secondary objectives: 1) To establish the tolerability and safety of Quetiapine XR versus Placebo in patients with co-morbid depressive and anxiety disorders;2) To assess and compare the efficacy of Quetiapine XR versus Placebo improving quality of life in patients with co-morbid depressive and anxiety disorders.; 3) To assess and compare the efficacy of Quetiapine XR versus Placebo on clinical measures symptoms associated to co-morbid depressive and anxiety disorders.

Conditions: Major Depressive Disorder, Dysthymic Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
Being tested: Quetiapine, Placebo
Keywords: Co-morbid depressive and anxiety disorders, Quetiapine, Randomized, Placebo-controlled, Double-blind, Major depressive disorder, Dysthymic disorder, Anxiety disorders, Generalized anxiety disorder, Social anxiety disorder, Panic disorder, Post-traumatic stress disorder
Medical subject headings: Depressive Disorder, Major, Dysthymic Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuetiapineDrug
Also called Seroquel
Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
PlaceboDrug
Patients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.

Study groups in NCT00688818
Study group	Role	What they receive
Quetiapine and existing psychotropics	Experimental	Not described Receives: Drug: Quetiapine
Placebo and existing psychotropics	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale (HAMD-17)
Measured: 12 weeks

Secondary outcomes (7)

Hamilton Anxiety Scale
Measured: Baseline, 6 weeks and 12 weeks
Quality of Life Enjoyment and Satisfaction Scale
Measured: Baseline, 6 weeks and 12 weeks
Penn State Worry Questionnaire
Measured: Baseline, 6 weeks and 12 weeks
Panic Disorder Severity Scale
Measured: Baseline, 6 weeks and 12 weeks
Leibowitz Social Anxiety Scale
Measured: Baseline, 6 weeks and 12 weeks
Post-traumatic Diagnostic Scale
Measured: Baseline, 6 weeks and 12 weeks
Clinical Global Impression Scale
Measured: Baseline, 6 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jun 2013

First posted3 Jun 2008 (estimated)
Study startJun 2008
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00688818
Sponsor's protocol ID: 183/2007
Status last verified: Aug 2014
First submitted: 30 May 2008
Last updated: 21 Aug 2014
Results posted: No
Data monitoring committee: Yes

Publications

Ravindran N, McKay M, Paric A, Johnson S, Chandrasena R, Abraham G, Ravindran AV. Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Comorbid Depressive and Anxiety Disorders. J Clin Psychiatry. 2022 Mar 21;83(3):21m14096. doi: 10.4088/JCP.21m14096.
PubMed 35324094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders
ClinicalTrials.gov ID: NCT00688818
Acronym / sponsor ID: 183/2007
Conditions: Major Depressive Disorder, Dysthymic Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
Keywords: Co-morbid depressive and anxiety disorders, Quetiapine, Randomized, Placebo-controlled, Double-blind, Major depressive disorder, Dysthymic disorder, Anxiety disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Centre for Addiction and Mental HealthUniversity, hospital or other
Study start: Jun 2008
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 3 Jun 2008 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Quetiapine and existing psychotropics	Experimental	Drug: Quetiapine
Placebo and existing psychotropics	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of written informed consent
Male and female patients must be of 18 to 65 years of age.
Women of childbearing potential must have a negative pregnancy test and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study.
A diagnosis of Major Depressive Disorder or Dysthymic Disorder as defined by DSM-IV criteria and failed to respond to at least one first line treatment. The patient must be receiving antidepressant treatment (SSRIs, SNRIs or mirtazapine).
A co-morbid diagnosis of one or more of the following: Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, and Post Traumatic Stress Disorder, and Obsessive-Compulsive Disorder, as defined by DSM-IV criteria

Key exclusion criteria (21 listed)

The presence or history of Psychotic Disorders, Bipolar Disorders, Mood Disorders with Psychotic Features
Patients who, in the investigator's judgment, would require treatment with additional psychotherapeutic drugs, electroconvulsive therapy (ECT), or intensive psychotherapy during the course of the study.
ECT within the preceding 6 months of screening before inclusion.
Regular, formal psychotherapy (excluding supportive therapy) started within the last 3 months before inclusion.
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

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
QuetiapineAlso: SeroquelPatients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.	Drug	Quetiapine and existing psychotropics
PlaceboPatients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.	Drug	Placebo and existing psychotropics

Primary outcome

Hamilton Depression Rating Scale (HAMD-17)
Time frame: 12 weeks

7 secondary outcomes

Hamilton Anxiety Scale
Time frame: Baseline, 6 weeks and 12 weeks
Quality of Life Enjoyment and Satisfaction Scale
Time frame: Baseline, 6 weeks and 12 weeks
Penn State Worry Questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
Panic Disorder Severity Scale
Time frame: Baseline, 6 weeks and 12 weeks
Leibowitz Social Anxiety Scale
Time frame: Baseline, 6 weeks and 12 weeks
Post-traumatic Diagnostic Scale
Time frame: Baseline, 6 weeks and 12 weeks
Clinical Global Impression Scale
Time frame: Baseline, 6 weeks and 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
Derived from this study: PubMed 35324094Ravindran N, McKay M, Paric A, Johnson S, Chandrasena R, Abraham G, Ravindran AV. Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Comorbid Depressive and Anxiety Disorders. J Clin Psychiatry. 2022 Mar 21;83(3):21m14096. doi: 10.4088/JCP.21m14096.
Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.

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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.

Arun Ravindran, MD, PhD principal investigator

Centre for Addiction and Mental Health

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Quetiapine in people with Major Depressive Disorder and Dysthymic Disorder, run by Centre for Addiction and Mental Health at 4 sites 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hamilton Depression Rating Scale (HAMD-17) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00688818, which also lists 1 linked publication.

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 21 Aug 2014.