Major Depressive DisorderBio-TestMDDNCT00705185
Exploring a Potential Blood Test to Diagnose Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
The purpose of this study is to develop a blood test for major depression and measure the effects of ziprasidone monotherapy on these markers. Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2008to Jun 2010
- Phase
- Observational
- 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
Study population: Adults with Major Depressive Disorder (DSM-IV)
Who may be able to join
- Age 18-65.
- Written informed consent.
- MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
- Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.
Who cannot join
- Pregnant women.
- Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
- Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
- Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
- Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
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- Patients who meet criteria for alcohol or substance dependence, active within the last month.
- Any bipolar disorder (current or past).
- Any psychotic disorder (current or past).
- Psychotic features in the current episode or a history of psychotic features.
- History of a seizure disorder.
- Clinical or laboratory evidence of untreated hypothyroidism.
- Patients requiring excluded medications (see table 1 for details).
- Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
- Any investigational psychotropic drug within the last 3 months.
- Patients with significant cardiac conduction problems on screening electrocardiogram such as atrial fibrillation, atrial flutter, atrio-ventricular block, prolonged or abnormal QTc interval (i.e. QTc>450msec), or prolonged QRS interval.
- Patients who have suffered a myocardial infarction within the past 12 months, with uncompensated heart failure, or a history of QTc prolongation.
- Patients with abnormal serum potassium or magnesium levels upon screening.
- Patients currently taking other drugs that prolong the QTc including dofetilide, sotalol, quinidine, class Ia antiarrhythmics, class III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron methylate, probucol or tacrolimus.
- Patients who have failed to experience significant clinical improvement following 3 or more antidepressant trials of adequate duration (at least 6 weeks) and dose (minimal effective doses defined as: fluoxetine, paroxetine, citalopram 20mg; sertraline, fluvoxamine 50mg, escitalopram 10mg, paroxetine CR 25mg, venlafaxine 75mg, duloxetine 60mg, bupropion 150mg, 15mg of mirtazapine, trazodone or nefazodone 300mg).
- The presence of Addison's or Cushing's disease.
- The presence of rheumatoid arthritis, or systemic lupus erythematosus.
- The regular use of non-steroidal anti-inflammatory medications or oral steroids.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hosptial
Boston, Massachusetts, 02114
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
Psychiatric Medicine Associates, L.L.C.
Chicago, Illinois, 60025
University of Connecticut Health Center
Farmington, Connecticut, 06030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Exploring Potential Serum/Plasma-Based Biomarkers as a Test for Major Depressive Disorder Diagnostics ("Bio-Test MDD")
The purpose of this study is to develop a blood test for major depression and measure the effects of ziprasidone monotherapy on these markers.
Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare these results to those of healthy controls" (defined as research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
Read the detailed description
This proposed study will be an ancillary study to clinical trial NCT00555997 (www.clinicaltrials.gov) entitled: "A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder" (MDD)." Precision Human Biolaboratory ("PHB") is attempting to develop a proprietary blood test intended to potentially serve as a biological marker ("bio-marker") for MDD. Specifically, PHB's research team will employ a unique approach towards developing a diagnostic test for MDD: measures from multiple blood-based biological markers will be obtained from patients with MDD and then analyzed with the use of several interrelated algorithms in order to derive a single biological measure ("bio-marker") with a high predictive value for MDD. PHBs' test panel of blood-based biological markers will consist of a number of cytokines, stress related hormones, and binding proteins that have each been linked to MDD. This innovative test panel is expected to provide general practice physicians with a tool to more accurately identify and classify patients with MDD which, in turn, could potentially , allow for the more effective monitoring of pharmacotherapy (antidepressant drug therapy). Thus, the development of a highly reliable biomarker for MDD could improve the standard of care for depression.
For this ancillary study, 120 antidepressant-free outpatients with MDD who have been deemed eligible to participate in trial NCT00555997 will be recruited from participating centers. Participating subjects will undergo a blood draw during the baseline visit for NCT00555997. Values obtained will be compared with those of "healthy controls" (defined as research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Blood Test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adults with Major Depressive Disorder- as defined by the criteria in the DSM-IV | |
| 2 | Healthy Controls- research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
16 Biological Markers; Group comparison between adults with Major Depressive Disorder and healthy controls
Measured: Screen visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
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 Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Precision Human Biolaboratories, Cambridge Health Alliance, University of Connecticut, Vanderbilt University, Psychiatric Medicine Associates, L.L.C.
- Investigators
- George I Papakostas, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705185
- Sponsor's protocol ID
- 2007-P-002525
- Acronym
- Bio-TestMDD
- Status last verified
- Jun 2010
- First submitted
- 23 Jun 2008
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Potential Serum/Plasma-Based Biomarkers as a Test for Major Depressive Disorder Diagnostics ("Bio-Test MDD")
- ClinicalTrials.gov ID
- NCT00705185
- Acronym / sponsor ID
- Bio-TestMDD / 2007-P-002525
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Blood Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Precision Human Biolaboratories, Cambridge Health Alliance, University of Connecticut, Vanderbilt University, Psychiatric Medicine Associates, L.L.C.
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 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.
The purpose of this study is to develop a blood test for major depression and measure the effects of ziprasidone monotherapy on these markers.
Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare these results to those of healthy controls" (defined as research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
Detailed description
This proposed study will be an ancillary study to clinical trial NCT00555997 (www.clinicaltrials.gov) entitled: "A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder" (MDD)." Precision Human Biolaboratory ("PHB") is attempting to develop a proprietary blood test intended to potentially serve as a biological marker ("bio-marker") for MDD. Specifically, PHB's research team will employ a unique approach towards developing a diagnostic test for MDD: measures from multiple blood-based biological markers will be obtained from patients with MDD and then analyzed with the use of several interrelated algorithms in order to derive a single biological measure ("bio-marker") with a high predictive value for MDD. PHBs' test panel of blood-based biological markers will consist of a number of cytokines, stress related hormones, and binding proteins that have each been linked to MDD. This innovative test panel is expected to provide general practice physicians with a tool to more accurately identify and classify patients with MDD which, in turn, could potentially , allow for the more effective monitoring of pharmacotherapy (antidepressant drug therapy). Thus, the development of a highly reliable biomarker for MDD could improve the standard of care for depression.
For this ancillary study, 120 antidepressant-free outpatients with MDD who have been deemed eligible to participate in trial NCT00555997 will be recruited from participating centers. Participating subjects will undergo a blood draw during the baseline visit for NCT00555997. Values obtained will be compared with those of "healthy controls" (defined as research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adults with Major Depressive Disorder- as defined by the criteria in the DSM-IV |
| 2 | – | –Healthy Controls- research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Major Depressive Disorder (DSM-IV)
Key inclusion criteria (4 listed)
- Age 18-65.
- Written informed consent.
- MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
- Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.
Key exclusion criteria (23 listed)
- Pregnant women.
- Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
- Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
- Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
- Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
16 Biological Markers; Group comparison between adults with Major Depressive Disorder and healthy controls
Time frame: Screen 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 8 Jun 2010.
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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.
George I Papakostas, M.D. principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Massachusetts General Hospital at 5 sites 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 4 inclusion and 23 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 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
16 Biological Markers; Group comparison between adults with Major Depressive Disorder and healthy controls (time frame: Screen visit). 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 8 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.