NCT01517360

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.1 years

First QC Date

January 19, 2012

Last Update Submit

March 27, 2013

Conditions

Schizophrenia

Keywords

SchizophreniaSocial CognitionOxytocin

Outcome Measures

Primary Outcomes (1)

  • Composite Social Cognition Score

    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.

    Baseline, 6 weeks, and 10 weeks

Study Arms (2)

Placebo+Social Cognitive Skills Training

ACTIVE COMPARATOR

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).

Other: PlaceboBehavioral: Social Cognitive Skills Training

Oxytocin+Social Cognitive Skill Training

EXPERIMENTAL

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).

Drug: OxytocinBehavioral: Social Cognitive Skills Training

Interventions

OxytocinDRUG

Oxytocin 40 IU, intranasal inhalation

Also known as: Syntocinon
Oxytocin+Social Cognitive Skill Training
PlaceboOTHER

Placebo, matched to Oxytocin, intranasal inhalation

Placebo+Social Cognitive Skills Training
Social Cognitive Skills TrainingBEHAVIORAL

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+Social Cognitive Skill TrainingPlacebo+Social Cognitive Skills Training

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

Related Publications (4)

  • 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.

    PMID: 8942455BACKGROUND

  • 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.

    PMID: 21377168BACKGROUND

  • 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.

    PMID: 19505497BACKGROUND

  • 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.

    PMID: 20615494BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Stephen R Marder, MD

    Department of Veterans Affairs, University of California Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, VA Desert Pacific Mental Illness Research, Education, and Clinical Center

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(1)