DepressionPhase 4NCT00375843
Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication
A Phase 4 study testing Escitalopram and Sertraline in people with Depression, run by National Institute of Mental Health (NIMH) at 3 sites in United States.
Trial summary
This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram and Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Mar 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently an outpatient with nonpsychotic, unipolar major depressive disorder (MDD)
- Score of 14 or greater on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Antidepressant treatment is deemed appropriate by the study clinician
- Willing to use an effective form of contraception throughout the study
Who cannot join
- Mentally or legally incapacitated
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, or dementia
- Patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
- History of substance abuse disorder within 6 months prior to study entry
- Current suicidal ideation that would make outpatient treatment unsafe
- Past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate (e.g., previous intolerance or lack of response to either medication)
Show all 13Show fewer
- History of a failed treatment with escitalopram (40 mg or more) or sertraline (200 mg or more) during the current depressive episode
- Any medical conditions that would make treatment with escitalopram or sertraline medically inadvisable
- Unstable medical illness
- Unstable psychiatric illness likely to require inpatient treatment within the 6 months following study entry
- History of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG
- Pregnant or plans to become pregnant within the 12 months following study entry
- Breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard/MGH
Boston, Massachusetts, 02114
UCLA Semel Institute
Los Angeles, California, 90095
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Response Variability in Treatment Resistant Depression - an Ancillary Study to "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)"
This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression.
Read the detailed description
Depression is a serious medical illness that is characterized by a persistent sad, anxious, or empty mood. Many treatments have been shown to relieve depression, including both medications and behavioral therapies. No single treatment, however, works for everyone. Approximately half of the people being treated for depression do not respond to the first medication they try. Studies have shown that some people with depression show changes in brain activity within 2 weeks of starting treatment, even though symptoms do not change until later. People who do not respond to treatment, however, do not exhibit these changes in brain activity. More information is needed to understand the different ways in which people with depression respond to medication. This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression. It will also determine whether the brain testing involved in this study is burdensome to the participants.
Individuals interested in taking part in this 1-year study will first attend one screening visit to determine their eligibility for participation. Before beginning treatment, all participants will have an electroencephalogram (EEG) to determine baseline brain activity. Participants will then receive up to 12 weeks of treatment with escitalopram, an antidepressant medication. Study visits will be held every 2 to 3 weeks during this phase. At the Week 2 visit, participants will have another EEG. Participants who respond to escitalopram by the end of the treatment phase will be asked to participate in a 6-month follow-up phase, in which participants will be followed by their own personal physicians, but will have the option to continue treatment with escitalopram. Follow-up visits will be held at Months 3 and 6. Participants who do not respond to escitalopram by the end of the treatment phase will have another EEG, and will then receive up to 12 weeks of treatment with sertraline, another antidepressant medication. Study visits will be held every 2 to 3 weeks, and participants will have a fourth EEG at Week 2. Participants who respond to sertraline will then enter the 6-month follow-up phase, and may continue receiving sertraline. Participants who do not improve with sertraline will receive referrals for additional care outside of the study.
- Conditions
- Depression
- Being tested
- Escitalopram, Sertraline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Level 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks.
SertralineDrug
Also called Zoloft
Level 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Level 1 Treatment: Escitalopram | Active comparator | Level 1 participants who are assigned to escitalopram Receives: Drug: Escitalopram |
| Level 2: Sertraline | Active comparator | Participants from Level 1 who do not achieve remission with escitalopram enter Level 2 and switch to sertraline Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between depression symptoms and brain physiologic measures
Measured: Measured at exit from Level 1 treatment or from Level 2 treatment (each 12 weeks duration)
Secondary outcomes (5)
Patient acceptability of EEG measures
Measured: Measured after final EEG recording
Relationship between brain physiologic measures and side effects
Measured: Measured at study exit
Relationship between brain physiologic measures and quality of life measures
Measured: Measured at study exit
Relationship between brain physiologic measures and psychosocial function measures
Measured: Measured at study exit
Relationship between brain physiologic measures and durability of remission, assessed as return of depressive symptoms during the 6 month follow-on phase
Measured: Measured at Month 6 of follow-on phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ian Cook, MD, Principal investigator, UCLA Semel Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375843
- Sponsor's protocol ID
- R01MH069217
- Other IDs
- DATR A5-ETMA, R01 MH069180 (Alpert)
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2006
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- 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 12062912
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Variability in Treatment Resistant Depression - an Ancillary Study to "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)"
- ClinicalTrials.gov ID
- NCT00375843
- Acronym / sponsor ID
- R01MH069217
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Sep 2006 (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 will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression.
Detailed description
Depression is a serious medical illness that is characterized by a persistent sad, anxious, or empty mood. Many treatments have been shown to relieve depression, including both medications and behavioral therapies. No single treatment, however, works for everyone. Approximately half of the people being treated for depression do not respond to the first medication they try. Studies have shown that some people with depression show changes in brain activity within 2 weeks of starting treatment, even though symptoms do not change until later. People who do not respond to treatment, however, do not exhibit these changes in brain activity. More information is needed to understand the different ways in which people with depression respond to medication. This study will examine how brain activity is affected by antidepressant treatment and how changes in brain activity relate to treatment response in people with depression. It will also determine whether the brain testing involved in this study is burdensome to the participants.
Individuals interested in taking part in this 1-year study will first attend one screening visit to determine their eligibility for participation. Before beginning treatment, all participants will have an electroencephalogram (EEG) to determine baseline brain activity. Participants will then receive up to 12 weeks of treatment with escitalopram, an antidepressant medication. Study visits will be held every 2 to 3 weeks during this phase. At the Week 2 visit, participants will have another EEG. Participants who respond to escitalopram by the end of the treatment phase will be asked to participate in a 6-month follow-up phase, in which participants will be followed by their own personal physicians, but will have the option to continue treatment with escitalopram. Follow-up visits will be held at Months 3 and 6. Participants who do not respond to escitalopram by the end of the treatment phase will have another EEG, and will then receive up to 12 weeks of treatment with sertraline, another antidepressant medication. Study visits will be held every 2 to 3 weeks, and participants will have a fourth EEG at Week 2. Participants who respond to sertraline will then enter the 6-month follow-up phase, and may continue receiving sertraline. Participants who do not improve with sertraline will receive referrals for additional care outside of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Level 1 Treatment: Escitalopram | Active comparator | Drug: EscitalopramLevel 1 participants who are assigned to escitalopram |
| Level 2: Sertraline | Active comparator | Drug: SertralineParticipants from Level 1 who do not achieve remission with escitalopram enter Level 2 and switch to sertraline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently an outpatient with nonpsychotic, unipolar major depressive disorder (MDD)
- Score of 14 or greater on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Antidepressant treatment is deemed appropriate by the study clinician
- Willing to use an effective form of contraception throughout the study
Key exclusion criteria (13 listed)
- Mentally or legally incapacitated
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, or dementia
- Patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
- History of substance abuse disorder within 6 months prior to study entry
- Current suicidal ideation that would make outpatient treatment unsafe
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 |
|---|---|---|
| EscitalopramAlso: LexaproLevel 1 of the study involves open-label treatment with escitalopram, up to 30 mg/day for up to 12 weeks. | Drug | Level 1 Treatment: Escitalopram |
| SertralineAlso: ZoloftLevel 2 of the study involves open-label treatment with sertraline, up to 200 mg/day for up to 12 weeks. | Drug | Level 2: Sertraline |
Primary outcome
Relationship between depression symptoms and brain physiologic measures
Time frame: Measured at exit from Level 1 treatment or from Level 2 treatment (each 12 weeks duration)
5 secondary outcomes
Patient acceptability of EEG measures
Time frame: Measured after final EEG recording
Relationship between brain physiologic measures and side effects
Time frame: Measured at study exit
Relationship between brain physiologic measures and quality of life measures
Time frame: Measured at study exit
Relationship between brain physiologic measures and psychosocial function measures
Time frame: Measured at study exit
Relationship between brain physiologic measures and durability of remission, assessed as return of depressive symptoms during the 6 month follow-on phase
Time frame: Measured at Month 6 of follow-on phase
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 6 Feb 2013.
- 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.
- Click here for the UCLA Depression Research websiteLink 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.
Ian Cook, MD principal investigator
UCLA Semel Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram and Sertraline in people with Depression, run by National Institute of Mental Health (NIMH) at 3 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 13 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 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Relationship between depression symptoms and brain physiologic measures (time frame: Measured at exit from Level 1 treatment or from Level 2 treatment (each 12 weeks duration)). 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 NCT00375843, which also lists 2 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 6 Feb 2013.