Depressive DisorderNCT00437827
rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
A study testing Star*D algorithm and rEEG-guided therapy in people with Depressive Disorder, run by MYnd Analytics at 13 sites in United States.
Trial summary
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modified Star*D Algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Star*D algorithm and rEEG-guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2006to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet criteria for both melancholic and atypical depression per this protocol.
- Have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the Medication History for Depression Case Report Form and for a minimum duration of treatment of at least 4 weeks. For purposes of the Study, augmentation will be considered a separate regimen.
- Able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and Ambien. See Appendix II for a list of the half-lives of medications.
Who cannot join
- History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
- Doesn't qualify via rEEG analysis due to:
- Potential physiologic abnormality
- Low abnormality in comparison to current rEEG database
- No strong prediction by rEEG analysis for any particular medication class
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
McClean Hospital/Harvard
Belmont, Massachusetts, 02478-9106
Harvard Medical School - Cambridge Hospital
Cambridge, Massachusetts, 02139
Rush University
Chicago, Illinois, 60612 / 60076
Radiant Research
Denver, Colorado, 80212
Behavioral Research Specialists
Glendale, California, 91204
Hawaii Clinical Research Center
Honolulu, Hawaii, 96826
University of California - Irvine
Irvine, California, 92868
Cornell University
New York, New York, 10021
Univ of TX Health Science Center
San Antonio, Texas, 78229
Shanti Research and Clinical Trials
San Bernardino, California, 92324
Stanford University
Stanford, California, 94305-5401
Alpha Behavioral Care, P.A.
Summit, New Jersey, 07901
Elite Clinical Trials
Wildomar, California, 92595
About this study
Official title: A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modified Star*D Algorithm. Qualified subjects will be randomized to the experimental (rEEG guided) group, or the control group and treated for 12 weeks. Medications utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating scales and medications are provided at no cost to the patient.
Read the detailed description
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modified Star*D Algorithm. Qualified subjects will be randomized to the experimental (rEEG guided) group, or the control group and treated for 10 weeks. Medications utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating scales and medications are provided at no cost to the patient.
To qualify for entry into the study, patients must be:
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder. Subjects may meet criteria for both melancholic and atypical depression.
- Have failed 1 or more SSRIs, or have failed 2 or more antidepressants in at least 2 drug classes.
And patients must not have:
- History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
Medications that can be used in this study are:
Anti-depressants: fluoxetine, sertraline, paroxetine, desipramine, imipramine, nortriptyline,amitriptyline, clomipramine, bupropion, venlafaxine
Stimulants \& MAO Inhibitors: moclobemide, tranylcypromine, selegiline, methylphenidate, dextroamphetamine, dexlevoamphetamine, pemoline, lamotrigine, topiramate
Benzodiazepines: lorazepam, clonazepam, alprazolam
Anti-convulsants: carbamazepine, lithium, divalproex, gabapentin
Beta Blockers: metoprolol, propranolol, atenolol
- Conditions
- Depressive Disorder
- Being tested
- Star*D algorithm, rEEG-guided therapy
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star*D algorithmOther
Also called Standard of Care
Standard of care based upon the therapies selected in the Star*D study.
rEEG-guided therapyOther
Also called EEG-based technology
An rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Each subject in this arm will receive depression therapy similar to that used by the Star*D study - a major depression study conducted in the United States (Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Am J Psychiatry 2006; 163:1905-1917) Receives: Other: Star*D algorithm |
| 2 | Experimental | Each subject in this arm will receive therapy based upon an individualized rEEG report which provides one or more treatment options with the highest probability of success. Receives: Other: rEEG-guided therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two group comparison of QIDS-SR16 and Q-LES-Q-SF
Measured: after 12 weeks of treatment
Secondary outcomes (1)
Two group comparison of MADRS, Clinical Global Improvement and Severity.
Measured: after 12 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startAug 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MYnd Analytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles DeBattista, MD, Principal investigator, Stanford UniversityGustavo Kinrys, M.D., Principal investigator, Cambridge HospitalSteven G Potkin, MD, Principal investigator, University of California, IrvineDaniel Hoffman, MD, Study chair, MYnd Analytics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437827
- Sponsor's protocol ID
- rEEGTRD010
- Other IDs
- CNSR #010
- Status last verified
- Oct 2009
- First submitted
- 17 Jan 2007
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
- ClinicalTrials.gov ID
- NCT00437827
- Acronym / sponsor ID
- rEEGTRD010
- Conditions
- Depressive Disorder
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MYnd AnalyticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Feb 2007 (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.
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modified Star*D Algorithm. Qualified subjects will be randomized to the experimental (rEEG guided) group, or the control group and treated for 12 weeks. Medications utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating scales and medications are provided at no cost to the patient.
Detailed description
This study is testing a process (rEEG)for selecting the most appropriate medication(s) to treat a patient's depression versus a control group being treated according to a standardized method, the modified Star*D Algorithm. Qualified subjects will be randomized to the experimental (rEEG guided) group, or the control group and treated for 10 weeks. Medications utilized in this study are currently marketed. All visits, physical exam, rEEG, labs, rating scales and medications are provided at no cost to the patient.
To qualify for entry into the study, patients must be:
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder. Subjects may meet criteria for both melancholic and atypical depression.
- Have failed 1 or more SSRIs, or have failed 2 or more antidepressants in at least 2 drug classes.
And patients must not have:
- History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
Medications that can be used in this study are:
Anti-depressants: fluoxetine, sertraline, paroxetine, desipramine, imipramine, nortriptyline,amitriptyline, clomipramine, bupropion, venlafaxine
Stimulants \& MAO Inhibitors: moclobemide, tranylcypromine, selegiline, methylphenidate, dextroamphetamine, dexlevoamphetamine, pemoline, lamotrigine, topiramate
Benzodiazepines: lorazepam, clonazepam, alprazolam
Anti-convulsants: carbamazepine, lithium, divalproex, gabapentin
Beta Blockers: metoprolol, propranolol, atenolol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Star*D algorithmEach subject in this arm will receive depression therapy similar to that used by the Star*D study - a major depression study conducted in the United States (Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Am J Psychiatry 2006; 163:1905-1917) |
| 2 | Experimental | Other: rEEG-guided therapyEach subject in this arm will receive therapy based upon an individualized rEEG report which provides one or more treatment options with the highest probability of success. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet criteria for both melancholic and atypical depression per this protocol.
- Have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the Medication History for Depression Case Report Form and for a minimum duration of treatment of at least 4 weeks. For purposes of the Study, augmentation will be considered a separate regimen.
- Able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and Ambien. See Appendix II for a list of the half-lives of medications.
Key exclusion criteria (7 listed)
- History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
- Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding inclusion, unless drug(s) half-life is known.
- Known pregnancy and/or lactation, or intent to become pregnant during this study.
- Doesn't qualify via rEEG analysis due to:
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 |
|---|---|---|
| Star*D algorithmAlso: Standard of CareStandard of care based upon the therapies selected in the Star*D study. | Other | 1 |
| rEEG-guided therapyAlso: EEG-based technologyAn rEEG report is based upon a process that utilizes a patient's drug-free QEEG to predict successful treatment strategies. | Other | 2 |
Primary outcome
Two group comparison of QIDS-SR16 and Q-LES-Q-SF
Time frame: after 12 weeks of treatment
1 secondary outcome
Two group comparison of MADRS, Clinical Global Improvement and Severity.
Time frame: after 12 weeks of therapy
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 27 Oct 2009.
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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.
Charles DeBattista, MD principal investigator
Stanford University
Gustavo Kinrys, M.D. principal investigator
Cambridge Hospital
Steven G Potkin, MD principal investigator
University of California, Irvine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Star*D algorithm and rEEG-guided therapy in people with Depressive Disorder, run by MYnd Analytics at 13 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 7 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 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Two group comparison of QIDS-SR16 and Q-LES-Q-SF (time frame: after 12 weeks of treatment). 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 27 Oct 2009.