Pharmacological Approach to Improve the Outcome of Social Cognition Training
27 marzo 2013 aggiornato da: Stephen R Marder, MD, VA Greater Los Angeles Healthcare System
This study will evaluate whether oxytocin will facilitate the learning of social cognitive skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training (SCST).
The primary hypothesis is that schizophrenia subjects who are treated with oxytocin will demonstrate greater improvements in a summary measure of social cognition than subjects treated with placebo over the course of SCST.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Individuals with schizophrenia often have serious deficits in their abilities to perceive and interpret socially relevant information. These deficits in social cognition can lead to misunderstanding the intentions of others and failing to interpret social signals that are important for successful social interactions. The relationship between social cognition and functioning has led our group to develop a research agenda that includes understanding the neural underpinnings of social cognitive deficits, measuring these impairments using brain-based biomarkers and clinical assessments, and enhancing our Social Cognitive Skills Training program to improve social cognition and promote recovery.
Oxytocin, which is a hormone and neurotransmitter, is believed to impact social cognition through increased orienting toward and attending to socially salient visual features. There is also evidence that oxytocinergic signaling is impaired in schizophrenia. With this research, we hope to learn whether administration of oxytocin will improve different aspects of social cognition by examining the effects of oxytocin versus placebo administered intranasally before each of 12 sessions of a social cognitive skills training program on measures of independent living, work and social functioning.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
27
Fase
- Fase 1
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
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California
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Los Angeles, California, Stati Uniti, 90073
- West Los Angeles VA Medical Center
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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
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition
- Stable on an antipsychotic medication
- No change in antipsychotic dose of >10% during the past 3 months
Exclusion Criteria:
- Unable to provide informed consent
- History of epilepsy
- Active medical conditions that would make the study unsafe
- History of serious head injury
- History of hyponatremia
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: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Placebo+Social Cognitive Skills Training
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
The treatment groups will include individuals who are assigned to placebo.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between placebo administration and start of training).
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Placebo, matched to Oxytocin, intranasal inhalation
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
|
|
Sperimentale: Oxytocin+Social Cognitive Skill Training
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
The treatment groups will include individuals who are assigned to oxytocin.
Each training session will last 90 minutes (1 hour training and 30 minutes between oxytocin administration and start of training).
|
The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation.
These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice.
The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks.
Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
Oxytocin 40 IU, intranasal inhalation
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite Social Cognition Score
Lasso di tempo: Baseline, 6 weeks, and 10 weeks
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We will assess emotion management, emotion perception, social context processing/social perception, theory of mind, attributional bias, and empathic accuracy.
The primary summary measure for each test will be mean-centered and standardized to create a Z-score that will be averaged to create a single composite score for social cognition, serving as the primary outcome measure.
Parallel follow-up analyses will be conducted on individual components to determine which measures are most affected by treatment.
Similar secondary analyses will be employed for the event related potential (ERP) and basic cognition measures.
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Baseline, 6 weeks, and 10 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Stephen R Marder, MD, Department of Veterans Affairs, University of California Los Angeles
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
- Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.
- Marder SR, Wirshing WC, Mintz J, McKenzie J, Johnston K, Eckman TA, Lebell M, Zimmerman K, Liberman RP. Two-year outcome of social skills training and group psychotherapy for outpatients with schizophrenia. Am J Psychiatry. 1996 Dec;153(12):1585-92. doi: 10.1176/ajp.153.12.1585.
- Horan WP, Kern RS, Tripp C, Hellemann G, Wynn JK, Bell M, Marder SR, Green MF. Efficacy and specificity of social cognitive skills training for outpatients with psychotic disorders. J Psychiatr Res. 2011 Aug;45(8):1113-22. doi: 10.1016/j.jpsychires.2011.01.015. Epub 2011 Mar 4.
- Heinrichs M, von Dawans B, Domes G. Oxytocin, vasopressin, and human social behavior. Front Neuroendocrinol. 2009 Oct;30(4):548-557. doi: 10.1016/j.yfrne.2009.05.005. Epub 2009 Jun 6.
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 2012
Completamento primario (Effettivo)
1 febbraio 2013
Completamento dello studio (Effettivo)
1 febbraio 2013
Date di iscrizione allo studio
Primo inviato
19 gennaio 2012
Primo inviato che soddisfa i criteri di controllo qualità
19 gennaio 2012
Primo Inserito (Stima)
25 gennaio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
29 marzo 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 marzo 2013
Ultimo verificato
1 marzo 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Promise # 0041
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