DepressionNCT00360399
Identifying Factors That Predict Antidepressant Treatment Response
A study testing Escitalopram, Duloxetine and Cognitive behavioral therapy (CBT) in people with Depression, run by Emory University at 2 sites in United States.
Trial summary
This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram, Duloxetine 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
- 344 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Apr 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
- Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
- Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Agrees to use an effective form of contraception and/or double barrier method
Who cannot join
- Previously treated for major depression with either medication or psychotherapy
- Current psychosis, dementia, eating disorder, or dissociative disorder
- History of bipolar disorder (I and II) or schizophrenia
- Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
- Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
- Presence of any acute or chronic medical disorder that could affect successful completion of the trial
Show all 11Show fewer
- Medical contraindications that would preclude treatment with escitalopram or duloxetine
- Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation)
- Pregnant or breastfeeding
- Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker)
- Medical conditions that could prevent the safe completion of a dexamethasone-corticotropin releasing factor (Dex-CRF) test (e.g., uncontrolled hypertension, significant abnormalities in EKG, anemia, known allergies against drugs)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Mood and Anxiety Disorders Program
Atlanta, Georgia, 30306
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Read the detailed description
Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.
Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.
A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.
- Conditions
- Depression
- Being tested
- Escitalopram, Duloxetine, Cognitive behavioral therapy (CBT)
- Keywords
- Escitalopram, Duloxetine, Cognitive Behavioral Therapy, PET, fMRI
- 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
Escitalopram 10 to 20 mg per day for 12 weeks
DuloxetineDrug
Also called Cymbalta
Duloxetine 30 to 60 mg per day for 12 weeks
Cognitive behavioral therapy (CBT)Behavioural
CBT will include 16 one-hour sessions provided over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Active comparator | Participants will receive treatment with escitalopram for 12 weeks Receives: Drug: Escitalopram |
| Duloxetine | Active comparator | Participants will receive treatment with duloxetine for 12 weeks Receives: Drug: Duloxetine |
| CBT | Active comparator | Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission From Major Depressive Episode in Intent to Treat Sample
The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
Measured: Up to 12 Weeks
Remission From Major Depressive Episode Among Participants Who Completed the Intervention
The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
Measured: Measured at Weeks 10 and 12
Secondary outcomes (4)
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:
- Non-response: <30% reduction from baseline
- Partial Response: 30-49% reduction from baseline
- Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
- Remission: HDRS score ≤7
Measured: Up to 12 Weeks
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:
- Non-response: <30% reduction from baseline
- Partial Response: 30-49% reduction from baseline
- Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7
- Remission: HDRS score ≤7
Measured: Measured at Weeks 10 and 12
Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
Measured: Measured at 6, 9, 12, 15, 18, 21, and 24 months
Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks
Measured: Measured after 12 weeks of combined treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2015
- Study completionApr 2015
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 (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 344 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, Helen Mayberg, Emory University
- Investigators
- Helen S. Mayberg, MD, Principal investigator, Emory UniversityW. Edward Craighead, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360399
- Sponsor's protocol ID
- IRB00024975
- Other IDs
- P50MH077083
- Status last verified
- Jul 2016
- First submitted
- 2 Aug 2006
- Last updated
- 30 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dunlop BW, Binder EB, Cubells JF, Goodman MM, Kelley ME, Kinkead B, Kutner M, Nemeroff CB, Newport DJ, Owens MJ, Pace TW, Ritchie JC, Rivera VA, Westen D, Craighead WE, Mayberg HS. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial. Trials. 2012 Jul 9;13:106. doi: 10.1186/1745-6215-13-106.
PubMed 22776534Dunlop BW, Cha J, Choi KS, Rajendra JK, Nemeroff CB, Craighead WE, Mayberg HS. Shared and Unique Changes in Brain Connectivity Among Depressed Patients After Remission With Pharmacotherapy Versus Psychotherapy. Am J Psychiatry. 2023 Mar 1;180(3):218-229. doi: 10.1176/appi.ajp.21070727. Epub 2023 Jan 18.
PubMed 36651624Brydges CR, Fiehn O, Mayberg HS, Schreiber H, Dehkordi SM, Bhattacharyya S, Cha J, Choi KS, Craighead WE, Krishnan RR, Rush AJ, Dunlop BW, Kaddurah-Daouk R; Mood Disorders Precision Medicine Consortium. Indoxyl sulfate, a gut microbiome-derived uremic toxin, is associated with psychic anxiety and its functional magnetic resonance imaging-based neurologic signature. Sci Rep. 2021 Oct 25;11(1):21011. doi: 10.1038/s41598-021-99845-1.
PubMed 34697401Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Kennedy JC, Dunlop BW, Craighead LW, Nemeroff CB, Mayberg HS, Craighead WE. Follow-up of monotherapy remitters in the PReDICT study: Maintenance treatment outcomes and clinical predictors of recurrence. J Consult Clin Psychol. 2018 Feb;86(2):189-199. doi: 10.1037/ccp0000279.
PubMed 29369664Dunlop BW, Rajendra JK, Craighead WE, Kelley ME, McGrath CL, Choi KS, Kinkead B, Nemeroff CB, Mayberg HS. Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder. Am J Psychiatry. 2017 Jun 1;174(6):533-545. doi: 10.1176/appi.ajp.2016.16050518. Epub 2017 Mar 24.
PubMed 28335622
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Antidepressant Treatment Response: The Emory CIDAR
- ClinicalTrials.gov ID
- NCT00360399
- Acronym / sponsor ID
- IRB00024975
- Conditions
- Depression
- Keywords
- Escitalopram, Duloxetine, Cognitive Behavioral Therapy, PET, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2006
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Posted 28 Jul 2016
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 compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Detailed description
Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.
Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.
A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Active comparator | Drug: EscitalopramParticipants will receive treatment with escitalopram for 12 weeks |
| Duloxetine | Active comparator | Drug: DuloxetineParticipants will receive treatment with duloxetine for 12 weeks |
| CBT | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
- Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
- Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Agrees to use an effective form of contraception and/or double barrier method
Key exclusion criteria (11 listed)
- Previously treated for major depression with either medication or psychotherapy
- Current psychosis, dementia, eating disorder, or dissociative disorder
- History of bipolar disorder (I and II) or schizophrenia
- Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
- Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
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: LexaproEscitalopram 10 to 20 mg per day for 12 weeks | Drug | Escitalopram |
| DuloxetineAlso: CymbaltaDuloxetine 30 to 60 mg per day for 12 weeks | Drug | Duloxetine |
| Cognitive behavioral therapy (CBT)CBT will include 16 one-hour sessions provided over 12 weeks. | Behavioural | CBT |
Primary outcome
Remission From Major Depressive Episode in Intent to Treat Sample
Time frame: Up to 12 Weeks
The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
Remission From Major Depressive Episode Among Participants Who Completed the Intervention
Time frame: Measured at Weeks 10 and 12
The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
4 secondary outcomes
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
Time frame: Up to 12 Weeks
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
Time frame: Measured at Weeks 10 and 12
Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
Time frame: Measured at 6, 9, 12, 15, 18, 21, and 24 months
Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
Time frame: Measured after 12 weeks of combined treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22776534Dunlop BW, Binder EB, Cubells JF, Goodman MM, Kelley ME, Kinkead B, Kutner M, Nemeroff CB, Newport DJ, Owens MJ, Pace TW, Ritchie JC, Rivera VA, Westen D, Craighead WE, Mayberg HS. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial. Trials. 2012 Jul 9;13:106. doi: 10.1186/1745-6215-13-106.
- Derived from this study: PubMed 36651624Dunlop BW, Cha J, Choi KS, Rajendra JK, Nemeroff CB, Craighead WE, Mayberg HS. Shared and Unique Changes in Brain Connectivity Among Depressed Patients After Remission With Pharmacotherapy Versus Psychotherapy. Am J Psychiatry. 2023 Mar 1;180(3):218-229. doi: 10.1176/appi.ajp.21070727. Epub 2023 Jan 18.
- Derived from this study: PubMed 34697401Brydges CR, Fiehn O, Mayberg HS, Schreiber H, Dehkordi SM, Bhattacharyya S, Cha J, Choi KS, Craighead WE, Krishnan RR, Rush AJ, Dunlop BW, Kaddurah-Daouk R; Mood Disorders Precision Medicine Consortium. Indoxyl sulfate, a gut microbiome-derived uremic toxin, is associated with psychic anxiety and its functional magnetic resonance imaging-based neurologic signature. Sci Rep. 2021 Oct 25;11(1):21011. doi: 10.1038/s41598-021-99845-1.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 29369664Kennedy JC, Dunlop BW, Craighead LW, Nemeroff CB, Mayberg HS, Craighead WE. Follow-up of monotherapy remitters in the PReDICT study: Maintenance treatment outcomes and clinical predictors of recurrence. J Consult Clin Psychol. 2018 Feb;86(2):189-199. doi: 10.1037/ccp0000279.
- Derived from this study: PubMed 28335622Dunlop BW, Rajendra JK, Craighead WE, Kelley ME, McGrath CL, Choi KS, Kinkead B, Nemeroff CB, Mayberg HS. Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder. Am J Psychiatry. 2017 Jun 1;174(6):533-545. doi: 10.1176/appi.ajp.2016.16050518. Epub 2017 Mar 24.
- Related InfoLink 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 S. Mayberg, MD principal investigator
Emory University
W. Edward Craighead, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram, Duloxetine and Cognitive behavioral therapy (CBT) in people with Depression, run by Emory University at 2 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 11 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2016). 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 From Major Depressive Episode in Intent to Treat Sample (time frame: Up to 12 Weeks). The study lists 2 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 NCT00360399, which also lists 6 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 30 Aug 2016.