Major DepressionPhase 4NCT00982345
Brain Imaging of Quetiapine Response in Anxious Depression
A Phase 4 study testing quetiapine (Seroquel XR) in people with Major Depression, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression
- What is being tested?
- quetiapine (Seroquel XR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of written informed consent
- A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females or Males aged 18 - 60 years
- Female subjects of childbearing potential must be using a reliable method of contraception and have a negative serum human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
- 17-item Hamilton Depression Rating Scale (HDRS) score > 15
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- Hamilton Anxiety Scale (HAM-A) score > 15
- Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire
- Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:
- Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
- No danger to self or others.
Who cannot join
- Pregnancy or lactation
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder
- Subjects 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
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- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrollment (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 four weeks prior to enrollment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrollment or randomization of treatment in the present study.
- Participation in another drug trial within four weeks prior enrollment into this study or longer in accordance with local requirements
- A subject with Diabetes Mellitus; people who develop hyperglycemia will be removed from the study
- An absolute neutrophil count (ANC) of 1.5 x 109 per liter
- Use of psychotropics in the past two weeks. If on fluoxetine in the past, then should not have been on this medication for four weeks.
- History of lack of response to Quetiapine extended release.
- Acutely suicidal or homicidal or requiring inpatient treatment.
- Metallic implants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Adult Psychiatry Clinic
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain.
Read the detailed description
This study will measure the activity and connectivity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with seroquel.
- Conditions
- Major Depression
- Being tested
- quetiapine (Seroquel XR)
- Keywords
- Depression, Anxiety, Seroquel, Quetiapine, fMRI, pictures
- Medical subject headings
- Depressive Disorder, Major, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine (Seroquel XR)Drug
Also called Seroquel XR
Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Open label Quetiapine | Other | Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks Receives: Drug: quetiapine (Seroquel XR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Rating Scale (HDRS)
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Measured: Started: March 2009 Ending March 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Amit Anand, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982345
- Sponsor's protocol ID
- 0901-13
- Status last verified
- Aug 2016
- First submitted
- 21 Sep 2009
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of Quetiapine Response in Anxious Depression
- ClinicalTrials.gov ID
- NCT00982345
- Acronym / sponsor ID
- 0901-13
- Conditions
- Major Depression
- Keywords
- Depression, Anxiety, Seroquel, Quetiapine, fMRI, pictures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what parts of the brain have increased or decreased connectivity when people are depressed and how Seroquel extended release (XR) changes this connectivity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain.
Detailed description
This study will measure the activity and connectivity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with seroquel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label Quetiapine | Other | Drug: quetiapine (Seroquel XR)Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of written informed consent
- A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females or Males aged 18 - 60 years
- Female subjects of childbearing potential must be using a reliable method of contraception and have a negative serum human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
Key exclusion criteria (20 listed)
- Pregnancy or lactation
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder
- Subjects 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
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 (Seroquel XR)Also: Seroquel XRSeroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment. | Drug | Open label Quetiapine |
Primary outcome
17-item Hamilton Depression Rating Scale (HDRS)
Time frame: Started: March 2009 Ending March 2011
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Amit Anand, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quetiapine (Seroquel XR) in people with Major Depression, run by Indiana University at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 30 Sep 2016. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
17-item Hamilton Depression Rating Scale (HDRS) (time frame: Started: March 2009 Ending March 2011). 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 30 Sep 2016.