- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00057577
Prevention of Recurrence in Depression With Drugs and CT (CPT3)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.
Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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-
Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Rush Medical Center - Treatment Research Unit
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Depression Research Unit, University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Vanderbilt Adult Outpatient Psychiatry
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Recurrent or chronic major depressive disorder
Exclusion Criteria:
- Current diagnosis of psychotic affective disorder
- History of nonaffective psychotic disorder
- Substance dependence last three months requiring detox
- Schizotypal, antisocial, or borderline personality disorder
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
|
CT sessions occur weekly during acute treatment and monthly during continuation.
Acute treatment may last up to 18 months.
Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery.
At recovery, patients receiving combined treatment discontinue CT.
Andere Namen:
Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed.
Acute treatment may last up to 18 months.
Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery.
All recovered patients are randomized a second time to either maintenance medication or medication withdrawal.
Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
Andere Namen:
|
Experimental: Medications alone
Participants will receive maintenance of antidepressant medication alone
|
Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed.
Acute treatment may last up to 18 months.
Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery.
All recovered patients are randomized a second time to either maintenance medication or medication withdrawal.
Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
Zeitfenster: Through month 18 of treatment
|
Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
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Through month 18 of treatment
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Number of Participants in Recovery According to the LIFE and HRSD
Zeitfenster: Through 36 months of treatment
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Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)
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Through 36 months of treatment
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Number of Participants in Recurrence According to the LIFE and HRSD
Zeitfenster: Measured up to Month 36 from recovery
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Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)
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Measured up to Month 36 from recovery
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serious Adverse Events
Zeitfenster: Throughout study, up to 54 months
|
Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study
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Throughout study, up to 54 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Steven D. Hollon, PhD, Vanderbilt University
- Hauptermittler: Jan A. Fawcett, MD, Rush Medical Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Khazanov GK, Xu C, Hollon SD, DeRubeis RJ, Thase ME. Adding cognitive therapy to antidepressant medications decreases suicidal ideation. J Affect Disord. 2021 Feb 15;281:183-191. doi: 10.1016/j.jad.2020.12.032. Epub 2020 Dec 8.
- Khazanov GK, Xu C, Dunn BD, Cohen ZD, DeRubeis RJ, Hollon SD. Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial. Behav Res Ther. 2020 Feb;125:103507. doi: 10.1016/j.brat.2019.103507. Epub 2019 Oct 31.
- DeRubeis RJ, Zajecka J, Shelton RC, Amsterdam JD, Fawcett J, Xu C, Young PR, Gallop R, Hollon SD. Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):237-245. doi: 10.1001/jamapsychiatry.2019.3900. Erratum In: JAMA Psychiatry. 2020 Jan 29;:
- Hollon SD, DeRubeis RJ, Fawcett J, Amsterdam JD, Shelton RC, Zajecka J, Young PR, Gallop R. Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1157-64. doi: 10.1001/jamapsychiatry.2014.1054.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01MH060713 (US NIH Stipendium/Vertrag)
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