DepressionPhase 4NCT00200902
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
A Phase 4 study testing Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro) and Interpersonal Clinical Interaction (ICI) in people with Depression, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro) and Interpersonal Clinical Interaction (ICI)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Laboratory of Brain, Behavior, and Pharmacology
Los Angeles, California, 90024
About this study
Official title: Factors of Treatment Response in Major Depressive Disorder
This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.
Read the detailed description
We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.
- Conditions
- Depression
- Being tested
- Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro), Placebo, Interpersonal Clinical Interaction (ICI)
- Keywords
- Major depressive disorder, MDD, Antidepressant
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)Drug
Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
PlaceboOther
Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
Interpersonal Clinical Interaction (ICI)Behavioural
Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
| Study group | Role | What they receive |
|---|---|---|
| MED | Active comparator | For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition:
MED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro) Receives: Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro) |
| Placebo (PBO) | Placebo comparator | Subjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets). Receives: Other: Placebo |
| Interpersonal Clinical Interaction (ICI) | Other | Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician. Receives: Behavioral: Interpersonal Clinical Interaction (ICI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as Assessed by Participants' Change in Depression Rating
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.
Measured: Baseline, Week 8
Average Change in 3 Weeks of Participant Treatment Expectations
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.
Measured: Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Change in Hamilton Depression Assessment Score
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Measured: Baseline,Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Eli Lilly and Company, Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Andrew F. Leuchter, University of California, Los Angeles
- Investigators
- Andrew F. Leuchter, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200902
- Sponsor's protocol ID
- R01AT002479-02
- Other IDs
- R01AT002479-02, 04-02-068
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2005
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11.
PubMed 25213159
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors of Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00200902
- Acronym / sponsor ID
- R01AT002479-02
- Conditions
- Depression
- Keywords
- Major depressive disorder, MDD, Antidepressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Eli Lilly and Company, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.
Detailed description
We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MED | Active comparator | Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition: MED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro) |
| Placebo (PBO) | Placebo comparator | Other: PlaceboSubjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets). |
| Interpersonal Clinical Interaction (ICI) | Other | Behavioral: Interpersonal Clinical Interaction (ICI)Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician. |
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 (3 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 |
|---|---|---|
| Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well. | Drug | MED |
| PlaceboSubjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well. | Other | Placebo (PBO) |
| Interpersonal Clinical Interaction (ICI)Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects. | Behavioural | Interpersonal Clinical Interaction (ICI) |
Primary outcome
Response as Assessed by Participants' Change in Depression Rating
Time frame: Baseline, Week 8
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.
Average Change in 3 Weeks of Participant Treatment Expectations
Time frame: Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.
Change in Hamilton Depression Assessment Score
Time frame: Baseline,Week 8
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25213159Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11.
- Depression Research - Click here for more information about this study: Psychobiologic Factors of the Placebo Response in MDDLink 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, MD 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 Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro) and Interpersonal Clinical Interaction (ICI) in people with 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 3 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 13 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response as Assessed by Participants' Change in Depression Rating (time frame: Baseline, Week 8). The study lists 3 primary outcomes in all. 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 NCT00200902, which also lists 1 linked publication.
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 13 Aug 2024.