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- Essai clinique NCT00177294
Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression
Geriatric Depression: Getting Better, Getting Well
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.
Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00178035
http://clinicaltrials.gov/show/NCT00178074
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosis of unipolar major depression
- Hamilton Rating Scale for Depression (HRSD) (17 item) score of 15 or higher
- Speaks English
- Willing to discontinue other psychotropic medications
- Availability of family member or other caregiver
- Hearing capacity adequate to respond to a raised conversational voice
Exclusion Criteria:
- Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any psychotic disorder
- Folstein Mini-Mental Status Exam (MMSE) of 17 or lower
- Suicidal
- History of treatment non-adherence in other Center protocols
- History of documented non-response to citalopram in other Center protocols
- History of non-tolerance to escitalopram therapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
|
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Autres noms:
16 sessions of interpersonal psychotherapy (IPT)
Autres noms:
|
Comparateur actif: 2
Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management(DCM) without interpersonal psychotherapy (IPT)
|
Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks.
Autres noms:
16 weeks of depression care management(DCM).
No psychotherapy will be provided.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Remission
Délai: Measured at Week 6 or 22
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Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item).
Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.
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Measured at Week 6 or 22
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Charles F. Reynolds III, MD, University of Pittsburgh Professor of Psychiatry, Neurology, and Neuroscience
Publications et liens utiles
Publications générales
- Andreescu C, Tudorascu DL, Butters MA, Tamburo E, Patel M, Price J, Karp JF, Reynolds CF 3rd, Aizenstein H. Resting state functional connectivity and treatment response in late-life depression. Psychiatry Res. 2013 Dec 30;214(3):313-21. doi: 10.1016/j.pscychresns.2013.08.007. Epub 2013 Oct 18.
- Reynolds CF 3rd, Dew MA, Martire LM, Miller MD, Cyranowski JM, Lenze E, Whyte EM, Mulsant BH, Pollock BG, Karp JF, Gildengers A, Szanto K, Dombrovski AY, Andreescu C, Butters MA, Morse JQ, Houck PR, Bensasi S, Mazumdar S, Stack JA, Frank E. Treating depression to remission in older adults: a controlled evaluation of combined escitalopram with interpersonal psychotherapy versus escitalopram with depression care management. Int J Geriatr Psychiatry. 2010 Nov;25(11):1134-41. doi: 10.1002/gps.2443.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Troubles de l'humeur
- La dépression
- Dépression
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Médicaments psychotropes
- Inhibiteurs de l'absorption de la sérotonine
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents de sérotonine
- Agents antidépresseurs
- Agents antidépresseurs, deuxième génération
- Citalopram
Autres numéros d'identification d'étude
- R01MH037869-01 (Subvention/contrat des NIH des États-Unis)
- DATR A4-GPS
- R01MH037869 (Subvention/contrat des NIH des États-Unis)
- 0404007
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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