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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

NCTNCT02144155 (opens ClinicalTrials.gov in a new tab)Other id120005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
14 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2012
Primary completion
Dec 2014
Completion
Dec 2014
First posted
21 May 2014 (estimated)
Last update posted
9 Dec 2019
Conditions
Schizophrenia

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. N/A

    Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

    NCT02144155

    Mar 2012 to Dec 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.

Interventions

  • Oxytocin: 24IU - 168 IUDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin: 24 IU - 168 IU

    Oxytocin twice daily for 3 weeks

  • Sham comparator

    Vehicle placebo

    Placebo for 3 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks

    Time frame · baseline and 28 weeks

    Registry description

    The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.

Secondary outcomes(5)

  1. Global Assessment of Functioning (GAF)

    Time frame · 28 weeks

    Registry description

    The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).

  2. Clinical Global Impression-Severity

    Time frame · 28 Weeks

    Registry description

    The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).

  3. Clinical Global Impression-Global Improvement (CGI-I)

    Time frame · 28 Weeks

    Registry description

    The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).

  4. Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)

    Time frame · 28 weeks

  5. Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)

    Time frame · 28 Weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· baseline and 28 weeks

Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks

GroupValue
All Participantsnot posted
Secondary and other outcome results(5)
Secondary outcome· 28 weeks

Global Assessment of Functioning (GAF)

GroupValue
All Participantsnot posted
Secondary outcome· 28 Weeks

Clinical Global Impression-Severity

GroupValue
All Participantsnot posted
Secondary outcome· 28 Weeks

Clinical Global Impression-Global Improvement (CGI-I)

GroupValue
All Participantsnot posted
Secondary outcome· 28 weeks

Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)

GroupValue
All Participantsnot posted
Secondary outcome· 28 Weeks

Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)

GroupValue
All Participantsnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All ParticipantsThis study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study.0 / 140 / 140 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Adult men or women, 18 years of age or older. 2. Meet DSM-IV criteria for Schizophrenia 3. Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study. 4. Must be on a therapeutic dose of 1 or 2 atypical antipsychotic medications (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks. 5. A minimum PANSS total score of 55 at baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. 6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline; 7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. 8. Must be able to use nasal spray 9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. Exclusion Criteria: 1. Are pregnant or are breastfeeding (negative pregnancy test at screening) 2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse 3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study 4. Are unsuitable in any way to participate in this study, in the opinion of the investigator. 5. Another current, primary DSM-IV diagnosis other than Schizophrenia

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