Identifying Factors That Predict Antidepressant Treatment Response
Predictors of Antidepressant Treatment Response: The Emory CIDAR
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30322
- Emory University School of Medicine
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Atlanta, Georgia, Egyesült Államok, 30306
- Emory University Mood and Anxiety Disorders Program
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: Escitalopram
Participants will receive treatment with escitalopram for 12 weeks
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Escitalopram 10 to 20 mg per day for 12 weeks
Más nevek:
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Aktív összehasonlító: Duloxetine
Participants will receive treatment with duloxetine for 12 weeks
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Duloxetine 30 to 60 mg per day for 12 weeks
Más nevek:
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Aktív összehasonlító: CBT
Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks
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CBT will include 16 one-hour sessions provided over 12 weeks.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Remission From Major Depressive Episode in Intent to Treat Sample
Időkeret: Up to 12 Weeks
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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.
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Up to 12 Weeks
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Remission From Major Depressive Episode Among Participants Who Completed the Intervention
Időkeret: Measured at Weeks 10 and 12
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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.
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Measured at Weeks 10 and 12
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
Időkeret: Up to 12 Weeks
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Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:
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Up to 12 Weeks
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Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
Időkeret: Measured at Weeks 10 and 12
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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:
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Measured at Weeks 10 and 12
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Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
Időkeret: Measured at 6, 9, 12, 15, 18, 21, and 24 months
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The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
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Measured at 6, 9, 12, 15, 18, 21, and 24 months
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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
Időkeret: Measured after 12 weeks of combined treatment
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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
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Measured after 12 weeks of combined treatment
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Helen S. Mayberg, MD, Emory University
- Kutatásvezető: W. Edward Craighead, PhD, Emory University
Publikációk és hasznos linkek
Általános kiadványok
- Storebo 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.
- 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.
- Brydges 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.
- Kennedy 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.
- Dunlop 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. Erratum In: Am J Psychiatry. 2017 Jun 1;174(6):604.
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Viselkedési tünetek
- Depresszió
- A gyógyszerek élettani hatásai
- Neurotranszmitter szerek
- A farmakológiai hatás molekuláris mechanizmusai
- Perifériás idegrendszeri szerek
- Fájdalomcsillapítók
- Érzékszervi rendszer ügynökei
- Pszichotróp szerek
- Szerotonin felvétel gátlók
- Neurotranszmitter felvétel gátlók
- Membrán transzport modulátorok
- Szerotonin szerek
- Antidepresszív szerek
- Dopamin szerek
- Antidepresszív szerek, második generáció
- Szerotonin és noradrenalin újrafelvétel gátlók
- Duloxetin-hidroklorid
- Citalopram
Egyéb vizsgálati azonosító számok
- IRB00024975
- P50MH077083 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .