Major Depressive DisorderPhase 4NCT00759122
Electroencephalography (EEG) Biomarkers of Response in Depression
A Phase 4 study testing venlafaxine (Effexor) in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
There are two specific aims of this project: 1. To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- venlafaxine (Effexor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2005
- 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
- All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2).
- Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only.
Who cannot join
- All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses:
- delirium or dementia
- substance-related disorders
- schizophrenia or other psychotic disorders, or eating disorders.
- In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
- Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Laboratory of Brain, Behavior, and Pharmacology
Los Angeles, California, 90024
About this study
Official title: EEG Biomarkers of Response in Depression
There are two specific aims of this project:
- To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine
- To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing
Read the detailed description
Our previous work indicates that a combination of neurophysiologic, symptom, and cognitive measures may predict response more accurately than brain functional measures alone. The purpose of this study is to replicate results from our earlier work using a similar study design (96-06-291-11), and also to prospectively gather additional information to substantiate that a more comprehensive approach to subject assessment will yield more accurate and reproducible prediction of treatment response.
One of the major challenges involved in clinical trials for major depressive disorder (MDD) is that of placebo response. The placebo response rate has been estimated at 20 - 50% of those subjects who enter a standard clinical trial for MDD. This high rate of response to placebo, which may not differ substantially from the response rate to medication, can make it difficult to demonstrate the efficacy of new antidepressant compounds. Identification of MDD subjects with a placebo responder (PR) phenotype, either at the beginning or end of a clinical trial, could have two major potential benefits. First, identification of placebo responders prior to enrollment in a clinical trial might make it possible to have restrictive entry criteria, excluding such subjects from the trial. Segregation of PR phenotype subjects a priori could reduce variance in the outcome data and increase the drug-placebo difference. This exclusion could reduce the number of subjects required for clinical trials and render the trials more efficient. Second, identification of a PR phenotype during a clinical trial could make it possible to distinguish "true medication" from placebo response. This distinction could make it possible to identify subgroups in the trial, enhancing precision in the study of medication effects.
Our research group has performed a series of placebo-controlled treatment trials in MDD and has used a combination of behavioral ratings, self-report, and neurophysiologic measurements with quantitative electroencephalography (QEEG) to identify predictors of both placebo response and medication response. The preliminary results from previous studies suggest that a combination of neurophysiologic, symptom, and cognitive measures may be useful for pretreatment prediction and/or early treatment detection of different types of treatment response.
In this study our primary goal is to assess the neurophysiologic, behavioral, and cognitive assessments of subjects with MDD in the setting of a clinical trial to replicate prospectively these initial results and more completely identify the characteristics of different types of treatment response in a clinical trial.
- Conditions
- Major Depressive Disorder
- Being tested
- venlafaxine (Effexor), placebo
- Keywords
- mdd, major depressive disorder, depression
- 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.
venlafaxine (Effexor)Drug
Matching capsules containing venlafaxine 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.
placeboDrug
Matching capsules containing placebo 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | VENLAFAXINE Receives: Drug: venlafaxine (Effexor) |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2005
- Study completionDec 2005
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 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG, Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Ian A Cook, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759122
- Sponsor's protocol ID
- Biomarkers in MDD
- Status last verified
- Sep 2008
- First submitted
- 23 Sep 2008
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Biomarkers of Response in Depression
- ClinicalTrials.gov ID
- NCT00759122
- Acronym / sponsor ID
- Biomarkers in MDD
- Conditions
- Major Depressive Disorder
- Keywords
- mdd, major depressive disorder, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Medtronic - MITG, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Nov 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 25 Sep 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.
There are two specific aims of this project:
- To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine
- To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing
Detailed description
Our previous work indicates that a combination of neurophysiologic, symptom, and cognitive measures may predict response more accurately than brain functional measures alone. The purpose of this study is to replicate results from our earlier work using a similar study design (96-06-291-11), and also to prospectively gather additional information to substantiate that a more comprehensive approach to subject assessment will yield more accurate and reproducible prediction of treatment response.
One of the major challenges involved in clinical trials for major depressive disorder (MDD) is that of placebo response. The placebo response rate has been estimated at 20 - 50% of those subjects who enter a standard clinical trial for MDD. This high rate of response to placebo, which may not differ substantially from the response rate to medication, can make it difficult to demonstrate the efficacy of new antidepressant compounds. Identification of MDD subjects with a placebo responder (PR) phenotype, either at the beginning or end of a clinical trial, could have two major potential benefits. First, identification of placebo responders prior to enrollment in a clinical trial might make it possible to have restrictive entry criteria, excluding such subjects from the trial. Segregation of PR phenotype subjects a priori could reduce variance in the outcome data and increase the drug-placebo difference. This exclusion could reduce the number of subjects required for clinical trials and render the trials more efficient. Second, identification of a PR phenotype during a clinical trial could make it possible to distinguish "true medication" from placebo response. This distinction could make it possible to identify subgroups in the trial, enhancing precision in the study of medication effects.
Our research group has performed a series of placebo-controlled treatment trials in MDD and has used a combination of behavioral ratings, self-report, and neurophysiologic measurements with quantitative electroencephalography (QEEG) to identify predictors of both placebo response and medication response. The preliminary results from previous studies suggest that a combination of neurophysiologic, symptom, and cognitive measures may be useful for pretreatment prediction and/or early treatment detection of different types of treatment response.
In this study our primary goal is to assess the neurophysiologic, behavioral, and cognitive assessments of subjects with MDD in the setting of a clinical trial to replicate prospectively these initial results and more completely identify the characteristics of different types of treatment response in a clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: venlafaxine (Effexor)VENLAFAXINE |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2).
- Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only.
Key exclusion criteria (6 listed)
- All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses:
- In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded.
- Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study.
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 |
|---|---|---|
| venlafaxine (Effexor)Matching capsules containing venlafaxine 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule. | Drug | 1 |
| placeboMatching capsules containing placebo 37.5 mg. WERE prepared by the UCLA Pharmacy for the initial phase of the study. After a one-week placebo lead-in, subjects WERE randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects received four capsules daily (subjects achieved a dose of 150 mg. of venlafaxine after 10 days). The first dose was administered in the morning, with subsequent capsules added on a b.i.d. schedule. | Drug | 2 |
Primary outcome
Not reported in the source record.
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 25 Sep 2008.
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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.
Ian A Cook, MD principal investigator
Professor
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 venlafaxine (Effexor) in people with Major Depressive Disorder, 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 2 inclusion and 6 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 25 Sep 2008. 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. Some participants in this study may receive a placebo. 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.
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 25 Sep 2008.