Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)

7 aprile 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

247

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: PHARM
lithium and venlafaxine
Droga: lithium and Venlafaxine
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
Sperimentale: STABLE
ECT + VLF + Li
Procedura: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Level of functioning (SF-36)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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])
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

  • Investigatore principale: Charles Kellner, MD, Icahn School of Medicine at Mount Sinai

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2010

Completamento primario (Effettivo)

1 settembre 2015

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

7 dicembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

8 dicembre 2009

Primo Inserito (Stima)

9 dicembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GCO 09-0429
  • U01MH055495 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su lithium and Venlafaxine

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Uganda

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi