DepressionPhase 4NCT01200901
Quetiapine in Melancholic Depression
A Phase 4 study testing Quetiapine in people with Depression and Healthy, run by University of Cincinnati at 1 site in United States.
Trial summary
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that: 1. quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Healthy
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- A diagnosis of major depression with melancholic features by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females and males aged 18-65 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
- Subjects will have a Hamilton Depression Rating Scale, 28-item version (HDRS-28) score of at least 20 at the baseline visit.
Who cannot join
- Pregnancy or lactation
- 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, 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, and St. John's Wort.
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation Women using oral contraceptives or other medications that directly affect estrogen or progesterone system in the body.
Show all 25Show fewer
- Subjects taking corticosteroids or other medications that directly influence HPA axis function
- Subjects with certain lifestyle habits (i.e. working night shift) that could affect the function of the HPA axis
- History of substance dependence in the past year or meets criteria for a substance abuse disorder in the past three months.
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Participation in another drug trial within 4 weeks prior to enrollment into this study
- An absolute neutrophil count (ANC) of 1.5 x 109 per liter
- Patients who have initiated a new psychotherapy or behavioral therapy from a mental health professional in the past 3 months
- A lifetime DSM-IV history of a psychotic disorder, a bipolar disorder, or dementia.
- History of psychosurgery
- Axis II disorder
- History of seizures, excluding febrile seizures in childhood.
- Clinically relevant abnormal laboratory results.
- Patients who have received monoamine oxidase inhibitors, tricyclics, SSRIs, antipsychotics, or lithium within two weeks prior to randomization, or fluoxetine within four weeks prior to randomization.
- Electroconvulsive therapy (ECT) within three months of start of study
- History of mental retardation.
- History of major neurological illness, including any history of significant head trauma.
- Contraindications to magnetic resonance imaging, including claustrophobia and/or the presence of ferrous material that might make an MRI scan hazardous.
- Patients will be excluded from the study if they indicate at screening that they know someone who has previously participated in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that:
- quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
- successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers.
- successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task (i.e. there will be a diminished post-treatment mean AUC for cortisol secretion after the stress task compared to the pre-treatment AUC values in the patient group)
Read the detailed description
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits). Ten demographically matched healthy subjects will receive the same fMRI investigations on two occasions in order to provide a healthy baseline comparison to permit interpretation of the patient findings (e.g., whether initial and final fMRI measures in patients are abnormal and to control for any adaptation to the task that may normally occur).
- Conditions
- Depression, Healthy
- Being tested
- Quetiapine
- Keywords
- depression, healthy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Open Label Quetiapine
quetiapine XR 100 - 300 mg (flexible dosing)
| Study group | Role | What they receive |
|---|---|---|
| Melancolic depression patients | Experimental | Patients with major depression will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
Measured: 8 weeks
Secondary outcomes (2)
normalization of limbic areas associated with increased salivary cortisol response to a stressful task
successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers.
Measured: 8 Weeks
successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Nelson, University of Cincinnati
- Investigators
- Erik Nelson, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200901
- Sponsor's protocol ID
- Nelson AZ-IIT
- Status last verified
- Jan 2013
- First submitted
- 7 Sep 2010
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response
- ClinicalTrials.gov ID
- NCT01200901
- Acronym / sponsor ID
- Nelson AZ-IIT
- Conditions
- Depression, Healthy
- Keywords
- depression, healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Sep 2010 (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.
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that:
- quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
- successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers.
- successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task (i.e. there will be a diminished post-treatment mean AUC for cortisol secretion after the stress task compared to the pre-treatment AUC values in the patient group)
Detailed description
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits). Ten demographically matched healthy subjects will receive the same fMRI investigations on two occasions in order to provide a healthy baseline comparison to permit interpretation of the patient findings (e.g., whether initial and final fMRI measures in patients are abnormal and to control for any adaptation to the task that may normally occur).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melancolic depression patients | Experimental | Drug: QuetiapinePatients with major depression will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent
- A diagnosis of major depression with melancholic features by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females and males aged 18-65 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
Key exclusion criteria (25 listed)
- Pregnancy or lactation
- 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, 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, and St. John's Wort.
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: Open Label Quetiapinequetiapine XR 100 - 300 mg (flexible dosing) | Drug | Melancolic depression patients |
Primary outcome
quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
Time frame: 8 weeks
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
2 secondary outcomes
normalization of limbic areas associated with increased salivary cortisol response to a stressful task
Time frame: 8 Weeks
successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task
Time frame: 8 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 18 Jan 2013.
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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.
Erik Nelson, MD principal investigator
University of Cincinnati
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 in people with Depression and Healthy, run by University of Cincinnati 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 6 inclusion and 25 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 18 Jan 2013. 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?
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?
quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features (time frame: 8 weeks). 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 18 Jan 2013.