Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
24 octobre 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
17
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
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Texas
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Dallas, Texas, États-Unis, 752390-9119
- University of Texas Southwestern Medical Center at Dallas
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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
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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.
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varied dose (5, 10, 15 mg qd) for 6 wks
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Spatial Working Memory (SWM) Between Errors for 6-move Problems
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Spatial Working Memory (SWM) Strategy Score
Délai: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of Life Enjoyment and Satisfaction Questionnaire
Délai: 6 weeks
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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.
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6 weeks
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Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
Délai: 6 weeks
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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.
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6 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
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 octobre 2005
Achèvement primaire (Réel)
1 janvier 2009
Achèvement de l'étude (Réel)
1 janvier 2009
Dates d'inscription aux études
Première soumission
23 janvier 2008
Première soumission répondant aux critères de contrôle qualité
5 février 2008
Première publication (Estimation)
6 février 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 octobre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 octobre 2012
Dernière vérification
1 mars 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Troubles de l'humeur
- La dépression
- Dépression
- Trouble dépressif majeur
- Trouble dépressif, résistant au traitement
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents antipsychotiques
- Agents tranquillisants
- Médicaments psychotropes
- Agents de sérotonine
- Agents antidépresseurs
- Agonistes de la dopamine
- Agents dopaminergiques
- Agonistes des récepteurs de la sérotonine 5-HT1
- Agonistes des récepteurs de la sérotonine
- Antagonistes des récepteurs de la sérotonine 5-HT2
- Antagonistes de la sérotonine
- Antagonistes des récepteurs de la dopamine D2
- Antagonistes de la dopamine
- Aripiprazole
Autres numéros d'identification d'étude
- 042004-011
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