Major DepressionPhase 4NCT00792168
Physiologic Monitoring of Antidepressant Response
A Phase 4 study testing venlafaxine (Effexor) in people with Major Depression, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Primary: 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; Secondary: to determine if cordance changes early in the course (i.e., prior to improvement in clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- 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
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Dec 1998
- 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 in the placebo controlled phase of the study having a score on the 17-item Ham-D > 18 (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
- 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 placebo-controlled phase of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Los Angeles, California, 90024
About this study
Official title: Physiologic Monitoring of Antidepressant Treatment Response
Primary: 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;
Secondary: to determine if cordance changes early in the course (i.e., prior to improvement in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not clinically indicated for a particular patient) are predictive of later clinical response.
Read the detailed description
After a one-week single-blind placebo lead in, subjects will be randomly assigned to either venlafaxine or placebo for 8 weeks. They will undergo 6 QEEG studies (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment), with examiner and self-ratings of mood, anxiety, and clinical status at the time of each recording (Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI) to assess improvement. Any subjects with significant deterioration in mood and/or suicidal ideation during the 8 week trial will be dropped from the study and placed in open treatment.
At the end of 8 weeks, code will be broken and all subjects will be maintained/re-assigned to open-label treatment with venlafaxine for an additional 10 months if they wish. However, if the subject's primary physician believes that another clinically available antidepressant would be indicated instead of venlafaxine (due to history of prior non-response to venlafaxine, etc.), the indicated antidepressant medication will be administered. The antidepressant medication recommended by the primary physician will be provided free of charge for a one-year period. Tricyclic antidepressants and monoamine oxidase inhibitors will not be included due to the greater possibility of serious clinical sequelae with these older medications. The open-label phase will consist of regular monitoring by the laboratory at intervals of three days and one week after beginning a new antidepressant medication, and then monthly clinical visits (or more frequently if clinically indicated) with QEEG recordings and assessments of mood and clinical status as above by the laboratory psychiatrist to ensure that the subject is getting appropriate care from his or her primary physician. Drug dose will be adjusted using standard clinical practice by the subject's primary physician in the community, and if the subject remains on venlafaxine, the dosage may be increased as high as 225 mg/day during this phase.
Subjects will have one additional follow-up QEEG at the end of the open-label phase or when significant clinical improvement is detected (defined as resolution of DSM-IV symptoms, or Ham-D < 9). After the subject's depression resolves, he or she will continue to be monitored and given medication free of charge for the remainder of the one-year period, but will be seen clinically only by the primary physician in the community. A study psychiatrist will be available for consultation in cases of clinical necessity until the primary physician can be contacted. Subjects for whom venlafaxine is not clinically indicated and/or subjects who refuse the placebo portion of the study may be allowed to bypass the placebo-controlled phase and proceed directly to the open-label phase.
- Conditions
- Major Depression
- Being tested
- venlafaxine (Effexor), placebo
- 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.
venlafaxine (Effexor)Drug
venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule
placeboOther
venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule
| Study group | Role | What they receive |
|---|---|---|
| 1. Venlafaxine | Active comparator | Not described Receives: Drug: venlafaxine (Effexor) |
| 2. Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative electroencephalography (QEEG)
Measured: 6 QEEG measurements (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment)
Secondary outcomes (1)
Clinical assessment measuresments: Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI)
Measured: 6 study visits: end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 1996
- Primary completionNov 1996
- Study completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew F Leuchter, MDe, Principal investigator, UCLA Department of Psychiatry and Biobeavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792168
- Sponsor's protocol ID
- 96-06-291
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2008
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Monitoring of Antidepressant Treatment Response
- ClinicalTrials.gov ID
- NCT00792168
- Acronym / sponsor ID
- 96-06-291
- Conditions
- Major Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 1996 (actual)
- Primary completion
- Nov 1996 (actual)
- Study completion
- Dec 1998 (actual)
- First posted
- 17 Nov 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.
Primary: 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;
Secondary: to determine if cordance changes early in the course (i.e., prior to improvement in clinical symptoms) of venlafaxine (or another antidepressant if venlafaxine is not clinically indicated for a particular patient) are predictive of later clinical response.
Detailed description
After a one-week single-blind placebo lead in, subjects will be randomly assigned to either venlafaxine or placebo for 8 weeks. They will undergo 6 QEEG studies (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment), with examiner and self-ratings of mood, anxiety, and clinical status at the time of each recording (Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI) to assess improvement. Any subjects with significant deterioration in mood and/or suicidal ideation during the 8 week trial will be dropped from the study and placed in open treatment.
At the end of 8 weeks, code will be broken and all subjects will be maintained/re-assigned to open-label treatment with venlafaxine for an additional 10 months if they wish. However, if the subject's primary physician believes that another clinically available antidepressant would be indicated instead of venlafaxine (due to history of prior non-response to venlafaxine, etc.), the indicated antidepressant medication will be administered. The antidepressant medication recommended by the primary physician will be provided free of charge for a one-year period. Tricyclic antidepressants and monoamine oxidase inhibitors will not be included due to the greater possibility of serious clinical sequelae with these older medications. The open-label phase will consist of regular monitoring by the laboratory at intervals of three days and one week after beginning a new antidepressant medication, and then monthly clinical visits (or more frequently if clinically indicated) with QEEG recordings and assessments of mood and clinical status as above by the laboratory psychiatrist to ensure that the subject is getting appropriate care from his or her primary physician. Drug dose will be adjusted using standard clinical practice by the subject's primary physician in the community, and if the subject remains on venlafaxine, the dosage may be increased as high as 225 mg/day during this phase.
Subjects will have one additional follow-up QEEG at the end of the open-label phase or when significant clinical improvement is detected (defined as resolution of DSM-IV symptoms, or Ham-D < 9). After the subject's depression resolves, he or she will continue to be monitored and given medication free of charge for the remainder of the one-year period, but will be seen clinically only by the primary physician in the community. A study psychiatrist will be available for consultation in cases of clinical necessity until the primary physician can be contacted. Subjects for whom venlafaxine is not clinically indicated and/or subjects who refuse the placebo portion of the study may be allowed to bypass the placebo-controlled phase and proceed directly to the open-label phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Venlafaxine | Active comparator | Drug: venlafaxine (Effexor) |
| 2. Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects in the placebo controlled phase of the study having a score on the 17-item Ham-D > 18 (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 (8 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 placebo-controlled phase of 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)venlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule | Drug | 1. Venlafaxine |
| placebovenlafaxine 37.5 mg. or placebo will be prepared by the UCLA Pharmacy for the initial phase of the study. For the open-label phase of the study, subjects will receive the medication and dosage that is clinically indicated by the subject's primary physician in the community. After a one-week placebo lead-in, subjects will be randomly assigned to receive one capsule of either venlafaxine or placebo, with the dosage increase every two days until subjects receive four capsules daily (subjects will achieve a dose 150 mg. of venlafaxine after 7 days). The first dose will be administered in the morning, with subsequent capsules added on a b.i.d. schedule | Other | 2. Placebo |
Primary outcome
quantitative electroencephalography (QEEG)
Time frame: 6 QEEG measurements (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment)
1 secondary outcome
Clinical assessment measuresments: Ham-D, MADRS, Ham-A, SCL-90, Beck, LIFE, and CGI)
Time frame: 6 study visits: end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized treatment
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 22 Dec 2025.
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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, MDe principal investigator
UCLA Department of Psychiatry and Biobeavioral Sciences
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 Depression, 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 8 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 22 Dec 2025. 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.
What does the primary outcome measure?
quantitative electroencephalography (QEEG) (time frame: 6 QEEG measurements (end of wash-in, and 48 hours, 1 week, 2 weeks, 4 weeks, and 8 weeks after randomized 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 22 Dec 2025.