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Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)

7 avril 2017 mis à jour par: Icahn School of Medicine at Mount Sinai
This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT.

This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy "usual care" comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM).

At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or psychiatric hospitalization.

Type d'étude

Interventionnel

Inscription (Réel)

247

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Georgia
      • Augusta, Georgia, États-Unis, 30912
        • Georgia Regents University
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Mayo Clinic
    • New Jersey
      • Hoboken, New Jersey, États-Unis, 07030
        • Hoboken University Medical Center (MSSM satellite site)
    • New York
      • Glen Oaks, New York, États-Unis, 11004
        • The Zucker Hillside Hospital North Shore-LIJ Health System
      • New York, New York, États-Unis, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, États-Unis, 10032
        • Columbia University/New York State Psychiatric Institute
      • White Plains, New York, États-Unis, 10605
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Duke University
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Wake Forest University Medical Center
    • Texas
      • Dallas, Texas, États-Unis, 75390
        • University of Texas Southwestern Medical Center at Dallas

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV
  • ECT is clinically indicated

Exclusion Criteria:

  • Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation
  • Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
Comparateur actif: PHARM
lithium and venlafaxine
Médicament: lithium and Venlafaxine
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
Expérimental: STABLE
ECT + VLF + Li
Procédure: ECT
Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at every week

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at every week
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 2

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 2
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 4

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 4
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 5

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 5
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 6

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 6
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 7

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 7
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 8

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 8
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 9

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 9
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 10

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 10
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 11

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 11
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 12

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 12
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 13

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 13
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 14

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 14
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 15

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 15
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 16

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 16
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 17

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 17
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 18

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 18
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 19

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 19
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 20

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 20
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 21

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 21
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 22

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 22
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured by a telephone interview at week 23

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured by a telephone interview at week 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Délai: Measured at clinic visits at week 24

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)

Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.

Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured at clinic visits at week 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Level of functioning (SF-36)
Délai: Measured at baseline
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at baseline
Level of functioning (SF-36)
Délai: Measured at week 4
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 4
Level of functioning (SF-36)
Délai: Measured at week 8
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 8
Level of functioning (SF-36)
Délai: Measured at week 12
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 12
Level of functioning (SF-36)
Délai: Measured at week 16
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 16
Level of functioning (SF-36)
Délai: Measured at week 20
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 20
Level of functioning (SF-36)
Délai: Measured at week 24
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 24
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at baseline
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at baseline
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 2
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 2
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 4
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 4
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 8
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 8
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 10
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 10
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 12
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 12
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 14
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 14
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 16
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 16
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 18
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 18
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 20
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 20
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 22
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 22
Tolerability (Mini Mental State Examination [MMSE])
Délai: Measured at week 24
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 24
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at baseline
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at baseline
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 4
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 4
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 8
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 8
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 12
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 12
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 16
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 16
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 20
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 20
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Délai: Measured at week 24
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured at week 24
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Délai: Measured at baseline
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured at baseline
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Délai: Measured at weeks 12
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured at weeks 12
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Délai: Measured at weeks 24
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured at weeks 24
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at baseline
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at baseline
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 2
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 2
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 4
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 4
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 6
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 6
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 8
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 8
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 10
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 10
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 12
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 12
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 14
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 14
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 16
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 16
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 18
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 18
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 20
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 20
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 22
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 22
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Délai: Measured at week 24
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured at week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

National Institute of Mental Health (NIMH)

Les enquêteurs

  • Chercheur principal: Charles Kellner, MD, Icahn School of Medicine at Mount Sinai

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 septembre 2015

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

7 décembre 2009

Première soumission répondant aux critères de contrôle qualité

8 décembre 2009

Première publication (Estimation)

9 décembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 avril 2017

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCO 09-0429
  • U01MH055495 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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