Major Depressive DisorderPhase 2UNIQUENCT00733668

Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

A Phase 2 study testing Quetiapine fumarate (Seroquel) in people with Major Depressive Disorder, run by AstraZeneca at 4 sites in Belgium.

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

An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Quetiapine fumarate (Seroquel)
How many people: Not given
Where: 4 sitesBelgium
Study dates: Mar 2006to Nov 2007
Phase: Phase 2
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

Inform consent
Male and female, age between 18 and 65 years.
Naïve to any atypical antipsychotic
A diagnosis of major depressive disorder

Who cannot join

No use of fluvoxamine
Patients with a history of bipolar I or II disorder
Diagnosis of psychotic major depression disorder

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

Research Site
Bruges
Research Site
Leuven
Research Site
Liège
Research Site
Sint-Truiden

Other trials in Belgium

About this study

Official title: An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.

Conditions: Major Depressive Disorder
Being tested: Quetiapine fumarate (Seroquel)
Keywords: considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate, antipsychotic
Medical subject headings: Depressive Disorder, Major

What participants receive

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

Quetiapine fumarate (Seroquel)Drug
Also called Seroquel
300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks

What is being measured

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

The Montgomery-Asberg Depression Scale (MADRS) score
Measured: Visit 1 - > 5

Secondary outcomes (3)

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)
Measured: Visit 1 - > 5 (1 week between each visit)
Sheehan Disability Scale (SDS) score
Measured: Visit 1 - > 5 (1 week between each visit)
The Symptom Checklist 90 Revisred (SCL-90-R) score
Measured: Visit 1 - > 5 (1 week between each visit)

Timeline

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

Mar 2006Nov 2007

First posted13 Aug 2008 (estimated)
Study startMar 2006
Primary completionNov 2007
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00733668
Sponsor's protocol ID: D1449C00009
Acronym: UNIQUE
Status last verified: Mar 2009
First submitted: 12 Aug 2008
Last updated: 25 Mar 2009
Results posted: No
Data monitoring committee: No

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 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.
ClinicalTrials.gov ID: NCT00733668
Acronym / sponsor ID: UNIQUE / D1449C00009
Conditions: Major Depressive Disorder
Keywords: considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 13 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (4 listed)

Inform consent
Male and female, age between 18 and 65 years.
Naïve to any atypical antipsychotic
A diagnosis of major depressive disorder

Key exclusion criteria (3 listed)

No use of fluvoxamine
Patients with a history of bipolar I or II disorder
Diagnosis of psychotic major depression disorder

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 fumarate (Seroquel)Also: Seroquel300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks	Drug	–

Primary outcome

The Montgomery-Asberg Depression Scale (MADRS) score
Time frame: Visit 1 - > 5

3 secondary outcomes

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)
Time frame: Visit 1 - > 5 (1 week between each visit)
Sheehan Disability Scale (SDS) score
Time frame: Visit 1 - > 5 (1 week between each visit)
The Symptom Checklist 90 Revisred (SCL-90-R) score
Time frame: Visit 1 - > 5 (1 week between each visit)

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 25 Mar 2009.

Related trials for Major Depressive Disorder

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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
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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.

Pr. Demyttenaere study director

KUL

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quetiapine fumarate (Seroquel) in people with Major Depressive Disorder, run by AstraZeneca at 4 sites in Belgium.

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 4 inclusion and 3 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 25 Mar 2009. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The Montgomery-Asberg Depression Scale (MADRS) score (time frame: Visit 1 - > 5). 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 NCT00733668.

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 25 Mar 2009.