Major Depressive DisorderNCT00367341

Imaging Predictors of Treatment Response in Depression

A study testing escitalopram and Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 60 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: escitalopram and Cognitive Behavioral Therapy (CBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Jul 2013
Phase: Interventional
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 21 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female patients between the ages of 18 and 60. (no subjects with first episode over age 50. This is an attempt to exclude patients with 'vascular depression' who have a potentially different pathophysiology and treatment response compared to idiopathic MDD.
DSM-IV criteria for unipolar Major Depressive Disorder.
HAM-D (24 item) score >/= 18 at Screening, >/= 15 at Baseline.
Co-morbid conditions (other than those listed under exclusion criteria below) will be accepted as long as MDD is the primary diagnosis (based on predominance and sequential development of symptoms).
Acceptable method of birth control (oral contraceptives, Depo-Provera, Norplant, condoms with spermicide. A vasectomy is acceptable in the framework of a stable monogamous relationship. Sexually inactive women must agree to contraception if they become sexually active during the study.
Educational level, degree of understanding and reliability so that participation is feasible.
Informed consent to participate and comply in the study.

Who cannot join

Known neurological disorders or documented head injury.
Serious and unstable medical illnesses including diabetes, cardiovascular disease and cancer.
Medical conditions with known mood changes (endocrine, autoimmune disorders)
Co-morbid DSM-IV Axis I Diagnoses
Lifetime history of Bipolar Disorder, Schizophrenia, and other Psychotic Disorders, or Obsessive Compulsive Disorder
Alcohol abuse or dependence within the past six months, psychoactive substance abuse or dependence within the past six months.

Show all 17Show fewer

Clinical evidence of a severe Personality Disorder that would impede participation or completion of a controlled trial.
ECT within the past 6 months.
Previous failure to achieve a much improved status on CGI-Improvement (the equivalent of >50% symptom reduction) with a course of CBT (defined as a minimum of 8 sessions during 8 weeks of a specified manual-driven therapy by a CBT trained therapist) or escitalopram (defined as a minimum of 6 weeks with the dose of 10 mgs achieved for at least 2 weeks)
Use of concomitant medications with the exception of:
Maintenance/prophylactic meds for stable medical conditions
Ambien 5-10 mgs may be prescribed for occasional use (up to a single dose a week for insomnia, as long as it is not the night before a clinic visit, PET/fMRI study or ratings.
Antidepressants will be discontinued for 7 days prior to the screening visit, which will be a minimum of a week before the baseline scan (5 weeks for fluoxetine, protryptyline).
Current treatment with weekly individual or group psychotherapy targeted at the depressive symptoms, including psychodynamic, interpersonal or cognitive-behavioral.
Currently responding to medication treatment, without clinical reasons to change (e.g. side effects). Will not enroll a subject who wishes to discontinue an effective treatment for the sake of participation in the research.
Woman who are pregnant, breast feeding or intending to become pregnant during the course of the study.
Contraindications for MRI: pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University School of Medicine
Atlanta, Georgia, 30322

Other trials in United States

About this study

While there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. More critically, there are also no reliable predictors that might anticipate failure to such standard treatments either alone or in combination. This project will characterize imaging-based brain subtypes that distinguish groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive behavior therapy (CBT), respectively. To define these subtypes, a prospectively-treated cohort of 100 patients will be randomized to receive either escitalopram (s-CIT) or CBT for the first 12 weeks, with non-remitters to either first treatment crossed over to receive an additional 12 weeks of treatment with combined treatment. Non-remitters to both treatments will thus define a relatively treatment resistant third subgroup. Resting-state 18F-fluoro-deoxyglucose (FDG) positron emission tomography (PET) scans will be acquired prior to initiating antidepressant therapy, with pre-treatment scan patterns associated with three possible outcomes (CBT remission, s-CIT remission, and non-remission to both) assessed using multivariate analytic methods. A second PET scan, acquired early in the treatment course, will be used to assess the likelihood of response to the specific treatment first assigned. The proposed studies are a first step towards defining brain-based biomarkers predictive of differential treatment outcome in major depression; most critically, patterns distinguishing patients at risk for treatment resistance. Identification of such biomarkers has additional implications for future testing of novel therapies in patients with distinct brain signatures, including development of evidence-based treatment algorithms for individual patients.

Read the detailed description

SPECIFIC AIMS Aim 1. To define baseline regional glucose metabolic patterns (measured using FDG PET) associated with differential clinical remission to each of two well-established, randomly delivered first-line antidepressant treatments-the SSRI escitalopram (s-CIT) or cognitive behavioral therapy (CBT) with cross-over treatment for non-remitters (sequential course of treatment model).

Aim 2. To define metabolic change patterns, occurring early in the course of both s-CIT and CBT, associated with successful and unsuccessful clinical remission to each intervention.

Conditions: Major Depressive Disorder
Being tested: escitalopram, Cognitive Behavioral Therapy (CBT)
Keywords: Depression, Treatment, Imaging
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.

escitalopramDrug
Also called Lexapro
Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy (CBT)Behavioural
Also called Talk Therapy
CBT will include 16 1 hour sessions provided over 12 weeks.

Study groups in NCT00367341
Study group	Role	What they receive
Escitalopram	Other	Not described Receives: Drug: escitalopram
Cognitive Behavioral Therapy	Other	Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks
# of study participants with Hamilton Depression-17-item score less than or equal to 7.
Measured: Measured at week 12

Secondary outcomes (1)

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score
Measured: Measured at week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Jul 2013

First posted22 Aug 2006 (estimated)
Study startAug 2006
Primary completionAug 2011
Study completionJul 2013

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 (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00367341
Sponsor's protocol ID: IRB00026176
Status last verified: Nov 2013
First submitted: 18 Aug 2006
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

McGrath CL, Kelley ME, Holtzheimer PE, Dunlop BW, Craighead WE, Franco AR, Craddock RC, Mayberg HS. Toward a neuroimaging treatment selection biomarker for major depressive disorder. JAMA Psychiatry. 2013 Aug;70(8):821-9. doi: 10.1001/jamapsychiatry.2013.143.
PubMed 23760393
McGrath CL, Kelley ME, Dunlop BW, Holtzheimer PE 3rd, Craighead WE, Mayberg HS. Pretreatment brain states identify likely nonresponse to standard treatments for depression. Biol Psychiatry. 2014 Oct 1;76(7):527-35. doi: 10.1016/j.biopsych.2013.12.005. Epub 2013 Dec 19.
PubMed 24462230

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Imaging Predictors of Treatment Response in Depression
ClinicalTrials.gov ID: NCT00367341
Acronym / sponsor ID: IRB00026176
Conditions: Major Depressive Disorder
Keywords: Depression, Treatment, Imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Aug 2006
Primary completion: Aug 2011 (actual)
Study completion: Jul 2013 (actual)
First posted: 22 Aug 2006 (estimated)
Results: Posted 9 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim 2. To define metabolic change patterns, occurring early in the course of both s-CIT and CBT, associated with successful and unsuccessful clinical remission to each intervention.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Escitalopram	Other	Drug: escitalopram
Cognitive Behavioral Therapy	Other	Behavioral: Cognitive Behavioral Therapy (CBT)

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female patients between the ages of 18 and 60. (no subjects with first episode over age 50. This is an attempt to exclude patients with 'vascular depression' who have a potentially different pathophysiology and treatment response compared to idiopathic MDD.
DSM-IV criteria for unipolar Major Depressive Disorder.
HAM-D (24 item) score >/= 18 at Screening, >/= 15 at Baseline.
Co-morbid conditions (other than those listed under exclusion criteria below) will be accepted as long as MDD is the primary diagnosis (based on predominance and sequential development of symptoms).
Acceptable method of birth control (oral contraceptives, Depo-Provera, Norplant, condoms with spermicide. A vasectomy is acceptable in the framework of a stable monogamous relationship. Sexually inactive women must agree to contraception if they become sexually active during the study.

Key exclusion criteria (17 listed)

Known neurological disorders or documented head injury.
Serious and unstable medical illnesses including diabetes, cardiovascular disease and cancer.
Medical conditions with known mood changes (endocrine, autoimmune disorders)
Co-morbid DSM-IV Axis I Diagnoses
ECT within the past 6 months.

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: LexaproParticipants will receive treatment with escitalopram for 12 weeks.	Drug	Escitalopram
Cognitive Behavioral Therapy (CBT)Also: Talk TherapyCBT will include 16 1 hour sessions provided over 12 weeks.	Behavioural	Cognitive Behavioral Therapy

Primary outcome

Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks
Time frame: Measured at week 12
# of study participants with Hamilton Depression-17-item score less than or equal to 7.

1 secondary outcome

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Time frame: Measured at week 12.

Results and safety

Results posted to the registry on 9 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Escitalopram	42	40
Cognitive Behavioral Therapy	40	40

Primary outcome: Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks

Time frame: Measured at week 12. Number. Unit: participants

Measure	Escitalopram n = 32	Cognitive Behavioral Therapy n = 31
Value	12	12

Population analysed: completed study participants in 12-week-trial

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Escitalopram	0 of 42 (0%)	33 of 42 (78.6%)	Not reported
Cognitive Behavioral Therapy	0 of 40 (0%)	21 of 40 (52.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23760393McGrath CL, Kelley ME, Holtzheimer PE, Dunlop BW, Craighead WE, Franco AR, Craddock RC, Mayberg HS. Toward a neuroimaging treatment selection biomarker for major depressive disorder. JAMA Psychiatry. 2013 Aug;70(8):821-9. doi: 10.1001/jamapsychiatry.2013.143.
Derived from this study: PubMed 24462230McGrath CL, Kelley ME, Dunlop BW, Holtzheimer PE 3rd, Craighead WE, Mayberg HS. Pretreatment brain states identify likely nonresponse to standard treatments for depression. Biol Psychiatry. 2014 Oct 1;76(7):527-35. doi: 10.1016/j.biopsych.2013.12.005. Epub 2013 Dec 19.
website with study informationLink 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.

Helen Mayberg, M.D. principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing escitalopram and Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Emory University 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 7 inclusion and 17 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 9 Jan 2014. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2014). 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?

Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks (time frame: Measured at week 12). 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 NCT00367341, 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 9 Jan 2014.