Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

24. oktober 2012 opdateret af: Prabha Sunderajan, University of Texas Southwestern Medical Center

Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function

Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater, 752390-9119
        • University of Texas Southwestern Medical Center at Dallas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18-65
  • Primary diagnosis of Major Depressive Disorder (MDD)
  • Completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
  • Hamilton Rating Scale for Depression, 17-item (HRSD17) score less than or equal to 14 and/or Clinical Global Impression - Severity (CGI-S) score less than or equal to 3
  • Self-reported difficulties with cognition and/or concentration, and an Inventory for Depressive Symptomatology Clinician-Rated, 30-item (IDS-C30) item #16 (Concentration and Decision Making) score less than or equal to 2
  • Ability to read and write in English (required because instructions for cognitive testing and several questionnaires are available only in English)

Exclusion Criteria:

  • Presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
  • Presence of known cardiovascular disease or seizure disorder.
  • Presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or Not Otherwise Specified [NOS]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
  • Presence of organic brain injury or dementia, based on a cutoff score of < 20 on the Mini Mental Status Examination (MMSE).
  • Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as described in Inclusion Criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
  • Hospitalization for mental illness within the past year.
  • For women, currently pregnant or planning to become pregnant in the next year.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Aripiprazole augmentation
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Medicin: Aripiprazole
varied dose (5, 10, 15 mg qd) for 6 wks
Andre navne:
  • Abilify

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
Tidsramme: baseline and 6 weeks
The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
baseline and 6 weeks
Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
Tidsramme: baseline and 6 weeks
The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
baseline and 6 weeks
Spatial Working Memory (SWM) Between Errors for 6-move Problems
Tidsramme: baseline and 6 weeks
The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.
baseline and 6 weeks
Spatial Working Memory (SWM) Strategy Score
Tidsramme: baseline and 6 weeks
The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.
baseline and 6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life Enjoyment and Satisfaction Questionnaire
Tidsramme: 6 weeks
The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.
6 weeks
Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
Tidsramme: 6 weeks
The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.
6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Texas Southwestern Medical Center

Samarbejdspartnere

Bristol-Myers Squibb

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

23. januar 2008

Først indsendt, der opfyldte QC-kriterier

5. februar 2008

Først opslået (Skøn)

6. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 042004-011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner