Depressive Disorder, MajorPhase 4NCT00229476
Study of Medication and Placebo Response in Major Depression
A Phase 4 study testing sertraline (Zoloft) in people with Depressive Disorder, Major, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- sertraline (Zoloft)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Mar 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Unipolar Major Depression
Who cannot join
- Substance Abuse, Psychotic Disorder, History of Severe Head Trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Neuropsychiatric Institute & Hospital
Los Angeles, California, 90024
About this study
The primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.
- Conditions
- Depressive Disorder, Major
- Being tested
- sertraline (Zoloft)
- Keywords
- Depression, EEG, QEEG, cordance, Zoloft, sertraline, placebo, electroencephalogram, brain, antidepressants
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline (Zoloft)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
Secondary outcomes (1)
brain electrical activity (EEG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Pfizer, Massachusetts General Hospital
- Investigators
- Andrew F. Leuchter, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229476
- Sponsor's protocol ID
- 03-08-033
- Other IDs
- H6U-US-X002, 04012549
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 2005
- Last updated
- 7 Nov 2016
- Results posted
- No
Publications
Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M. Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry. 2002 Jan;159(1):122-9. doi: 10.1176/appi.ajp.159.1.122.
PubMed 11772700Cook IA, Leuchter AF, Morgan M, Witte E, Stubbeman WF, Abrams M, Rosenberg S, Uijtdehaage SH. Early changes in prefrontal activity characterize clinical responders to antidepressants. Neuropsychopharmacology. 2002 Jul;27(1):120-31. doi: 10.1016/S0893-133X(02)00294-4.
PubMed 12062912Leuchter AF, Morgan M, Cook IA, Dunkin J, Abrams M, Witte E. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology (Berl). 2004 Dec;177(1-2):15-22. doi: 10.1007/s00213-004-1919-2. Epub 2004 Jul 14.
PubMed 15252704
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Medication and Placebo Response in Major Depression
- ClinicalTrials.gov ID
- NCT00229476
- Acronym / sponsor ID
- 03-08-033
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression, EEG, QEEG, cordance, Zoloft, sertraline, placebo, electroencephalogram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Pfizer, Massachusetts General Hospital
- Study start
- Dec 2003
- Primary completion
- Mar 2006 (actual)
- First posted
- 29 Sep 2005 (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 primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Unipolar Major Depression
Key exclusion criteria (1 listed)
- Substance Abuse, Psychotic Disorder, History of Severe Head Trauma
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 |
|---|---|---|
| sertraline (Zoloft) | Drug | – |
Primary outcome
depressive symptoms
1 secondary outcome
brain electrical activity (EEG)
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 7 Nov 2016.
- Background: PubMed 11772700Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M. Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry. 2002 Jan;159(1):122-9. doi: 10.1176/appi.ajp.159.1.122.
- Background: PubMed 12062912Cook IA, Leuchter AF, Morgan M, Witte E, Stubbeman WF, Abrams M, Rosenberg S, Uijtdehaage SH. Early changes in prefrontal activity characterize clinical responders to antidepressants. Neuropsychopharmacology. 2002 Jul;27(1):120-31. doi: 10.1016/S0893-133X(02)00294-4.
- Background: PubMed 15252704Leuchter AF, Morgan M, Cook IA, Dunkin J, Abrams M, Witte E. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology (Berl). 2004 Dec;177(1-2):15-22. doi: 10.1007/s00213-004-1919-2. Epub 2004 Jul 14.
- Depression Research at UCLA - Click here for more information about this study: Study of Medication and Placebo Response in Major DepressionLink provided by the sponsor.
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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.
Andrew F. Leuchter, M.D. principal investigator
University of California, Los Angeles
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 sertraline (Zoloft) in people with Depressive Disorder, Major, run by University of California, Los Angeles 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 1 inclusion and 1 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 7 Nov 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?
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?
depressive symptoms. 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 NCT00229476, which also lists 3 linked publications.
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 7 Nov 2016.