DepressionPhase 4ISLANDNCT02137369
The ISLAND Study: InSuLa Assessed Needs for Depression
A Phase 4 study testing Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Combination treatment (SSRI + CBT) in people with Depression, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Combination treatment (SSRI + CBT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 24 Oct 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women aged 18-60 years.
- Primary psychiatric diagnosis of Major Depressive Disorder, without psychotic features, confirmed via SCID-IV structured diagnostic interview.
- Screening Hamilton Depression Rating Scale (HAMD) ≥ 18; and Baseline HAMD ≥ 15.
- If the patient is a woman of child-bearing potential, she must agree to use an acceptable form of birth control for duration of study participation.
- Able to understand and provide informed consent for participation.
Who cannot join
- Lifetime history of Bipolar Disorder, Dementia, Autism Spectrum Disorder, Schizophrenia, or any other Psychotic Disorder.
- Psychotic symptoms occurring at any time during the current major depressive episode.
- Current (past 12 months) diagnosis of Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa.
- Alcohol or Drug Dependence within 12 months or Abuse within 3 months (excluding nicotine and caffeine) of baseline visit, as assessed by history and urine drug screen.
- Clinical evidence of a severe Personality Disorder, as assessed by the study psychiatrist, which would impede participation or completion of the trial.
- Known neurological disorders or documented serious head injury.
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- Serious and unstable medical illnesses including cardiovascular disease and cancer.
- Active medical conditions with known mood changes (endocrine, autoimmune disorders).
- Current diabetes mellitus.
- For women, pregnancy, lactation, or unwillingness to comply with birth control requirements.
- Use of any of the following treatments or any other alternative therapy within 2 weeks of the pre-treatment PET scan that may have beneficial effects on mood, including St John's Wort, S-adenosyl methionine (SAMe), n-3 fatty acids, or light therapy.
- Use of antidepressant medication within 1 month of the pre-treatment PET scan (within 5 weeks for fluoxetine and protryptyline).
- Failure to achieve a much improved status (i.e. equivalent to >50% symptom reduction) with 1) any lifetime treatment course of CBT (defined as a minimum of 4 sessions of a specified manual-driven therapy by a CBT-trained therapist) or 2) both escitalopram and sertraline (defined as a minimum of 6 weeks of at the minimum effective dose).
- Clinically significant active suicidal ideation or self-injurious behavior necessitating immediate treatment, as determined by the investigator.
- Received electroconvulsive therapy in the past 6 months or during the current depressive episode.
- Currently responding to medication treatment, without clinical reasons to change.
- Current treatment with weekly individual or group psychotherapy of any type targeted at depressive symptoms.
- QTc >500 milliseconds on EKG at screening.
- Contraindications for MRI, including, but not limited to pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, intra-uterine devices for birth control.
- Use of concomitant medications with the exception of:
- Maintenance or prophylactic therapy for stable medical conditions.
- Hypnotic medication prescribed or approved by the study physician, (up to a three doses per week) for insomnia, as long if not the night before a PET/MRI or clinic ratings visit. Antipsychotic medications, whether prescribed for sleep or other indications, are prohibited.
Trial locations and contacts
1 site in 1 country.
United States1 site
12 Executive Park Drive, 3rd floor
Atlanta, Georgia, 30329
About this study
Official title: Testing an Imaging Biomarker for Treatment Stratification in Major Depression
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. The goal of this study is to test how brain function changes in depress patients treated with cognitive behavioral therapy (CBT) compared to patients treated with a selective serotonin reuptake inhibitor (SSRI, either escitalopram or sertraline), which are FDA approved antidepressants. The study aims to determine if bran scan findings might help physicians to select the most effective antidepressant treatment for an individual patient.
Up to 100 male and female outpatients who are between 21-55 years old will be enrolled. Participation in the study will last from 14-26 weeks.
Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks. Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance imaging (fMRI) scans will be done before the treatment begins, and again at the end of treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an additional 12 weeks of treatment with the alternative intervention.
- Conditions
- Depression
- Being tested
- Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy, Combination treatment (SSRI + CBT)
- Keywords
- MDD, Major Depressive Disorder, Treatment, Antidepressants, Lexapro, Talk therapy
- 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.
Selective serotonin re-uptake inhibitorDrug
Also called Escitalopram or Sertraline, SSRI, Antidepressant medication, Depression treatment
Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks
Cognitive Behavioral TherapyBehavioural
Also called CBT, Depression Treatment, Talk therapy
Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
Combination treatment (SSRI + CBT)Other
Also called Crossover treatment, escitalopram, depression treatment, antidepressant
study participants who do not remit in the first 12 weeks will be offered combination treatment of both treatments for 12 more weeks.
| Study group | Role | What they receive |
|---|---|---|
| SSRI | Active comparator | Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks or Sertraline, pill form, 50 - 150 mg, daily for 12 weeks Receives: Drug: Selective serotonin re-uptake inhibitor; Other: Combination treatment (SSRI + CBT) |
| Cognitive Behavioral Therapy | Active comparator | Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks. Receives: Behavioral: Cognitive Behavioral Therapy; Other: Combination treatment (SSRI + CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Remission From Major Depressive Episode Events
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
Measured: 12 weeks
Secondary outcomes (1)
Number of Response to Treatment Events
Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startSep 2014
- Primary completion24 Oct 2019
- Study completion24 Oct 2019
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Boadie W. Dunlop, Emory University
- Investigators
- Boadie W Dunlop, MD/MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137369
- Sponsor's protocol ID
- IRB00073702
- Other IDs
- R01MH073719, 00073702
- Acronym
- ISLAND
- Status last verified
- Oct 2020
- First submitted
- 12 May 2014
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kelley ME, Choi KS, Rajendra JK, Craighead WE, Rakofsky JJ, Dunlop BW, Mayberg HS. Establishing Evidence for Clinical Utility of a Neuroimaging Biomarker in Major Depressive Disorder: Prospective Testing and Implementation Challenges. Biol Psychiatry. 2021 Aug 15;90(4):236-242. doi: 10.1016/j.biopsych.2021.02.966. Epub 2021 Feb 26.
PubMed 33896622
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Imaging Biomarker for Treatment Stratification in Major Depression
- ClinicalTrials.gov ID
- NCT02137369
- Acronym / sponsor ID
- ISLAND / IRB00073702
- Conditions
- Depression
- Keywords
- MDD, Major Depressive Disorder, Treatment, Antidepressants, Lexapro, Talk therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2014
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The goal of this study is to test how brain function changes in depress patients treated with cognitive behavioral therapy (CBT) compared to patients treated with a selective serotonin reuptake inhibitor (SSRI, either escitalopram or sertraline), which are FDA approved antidepressants. The study aims to determine if bran scan findings might help physicians to select the most effective antidepressant treatment for an individual patient.
Up to 100 male and female outpatients who are between 21-55 years old will be enrolled. Participation in the study will last from 14-26 weeks.
Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks. Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance imaging (fMRI) scans will be done before the treatment begins, and again at the end of treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an additional 12 weeks of treatment with the alternative intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSRI | Active comparator | Drug: Selective serotonin re-uptake inhibitor, Other: Combination treatment (SSRI + CBT)Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks or Sertraline, pill form, 50 - 150 mg, daily for 12 weeks |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy, Other: Combination treatment (SSRI + CBT)Cognitive Behavioral Therapy (CBT) CBT will include 16 1-hour sessions provided over 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or women aged 18-60 years.
- Primary psychiatric diagnosis of Major Depressive Disorder, without psychotic features, confirmed via SCID-IV structured diagnostic interview.
- Screening Hamilton Depression Rating Scale (HAMD) ≥ 18; and Baseline HAMD ≥ 15.
- If the patient is a woman of child-bearing potential, she must agree to use an acceptable form of birth control for duration of study participation.
- Able to understand and provide informed consent for participation.
Key exclusion criteria (22 listed)
- Lifetime history of Bipolar Disorder, Dementia, Autism Spectrum Disorder, Schizophrenia, or any other Psychotic Disorder.
- Psychotic symptoms occurring at any time during the current major depressive episode.
- Current (past 12 months) diagnosis of Panic disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, or Bulimia Nervosa.
- Alcohol or Drug Dependence within 12 months or Abuse within 3 months (excluding nicotine and caffeine) of baseline visit, as assessed by history and urine drug screen.
- Clinical evidence of a severe Personality Disorder, as assessed by the study psychiatrist, which would impede participation or completion of the trial.
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 |
|---|---|---|
| Selective serotonin re-uptake inhibitorAlso: Escitalopram or Sertraline, SSRI, Antidepressant medication, Depression treatmentEscitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks | Drug | SSRI |
| Cognitive Behavioral TherapyAlso: CBT, Depression Treatment, Talk therapyCognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks. | Behavioural | Cognitive Behavioral Therapy |
| Combination treatment (SSRI + CBT)Also: Crossover treatment, escitalopram, depression treatment, antidepressantstudy participants who do not remit in the first 12 weeks will be offered combination treatment of both treatments for 12 more weeks. | Other | Cognitive Behavioral Therapy, SSRI |
Primary outcome
Number of Remission From Major Depressive Episode Events
Time frame: 12 weeks
Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale.
1 secondary outcome
Number of Response to Treatment Events
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33896622Kelley ME, Choi KS, Rajendra JK, Craighead WE, Rakofsky JJ, Dunlop BW, Mayberg HS. Establishing Evidence for Clinical Utility of a Neuroimaging Biomarker in Major Depressive Disorder: Prospective Testing and Implementation Challenges. Biol Psychiatry. 2021 Aug 15;90(4):236-242. doi: 10.1016/j.biopsych.2021.02.966. Epub 2021 Feb 26.
- 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.
Boadie W Dunlop, MD/MS 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 Phase 4 study testing Selective serotonin re-uptake inhibitor, Cognitive Behavioral Therapy and Combination treatment (SSRI + CBT) in people with Depression, 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 5 inclusion and 22 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 5 Nov 2020. 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.
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 5 Nov 2020). 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?
Number of Remission From Major Depressive Episode Events (time frame: 12 weeks). 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 NCT02137369, 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 5 Nov 2020.