Pharmacological Approach to Improve the Outcome of Social Cognition Training
27 maart 2013 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
27
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90073
- West Los Angeles VA Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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).
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Experimenteel: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Composite Social Cognition Score
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Stephen R Marder, MD, Department of Veterans Affairs, University of California Los Angeles
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2012
Primaire voltooiing (Werkelijk)
1 februari 2013
Studie voltooiing (Werkelijk)
1 februari 2013
Studieregistratiedata
Eerst ingediend
19 januari 2012
Eerst ingediend dat voldeed aan de QC-criteria
19 januari 2012
Eerst geplaatst (Schatting)
25 januari 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
29 maart 2013
Laatste update ingediend die voldeed aan QC-criteria
27 maart 2013
Laatst geverifieerd
1 maart 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Promise # 0041
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