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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Antipsychotic Effects of Oxytocin

NCTNCT01621737 (opens ClinicalTrials.gov in a new tab)Other id111017Other idR34MH091285
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
42 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jun 2011
Primary completion
Dec 2018
Completion
Dec 2018
First posted
18 Jun 2012 (estimated)
Last update posted
19 Nov 2019
Conditions
Schizophrenia

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. N/A

    Antipsychotic Effects of Oxytocin

    NCT01621737

    Jun 2011 to Dec 2018

    Terminated

Registry summary

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

The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

Interventions

  • OxytocinDrug
  • OxytocinDrug
  • PlaceboDrug

Arms3

  • Experimental

    Oxytocin: Low Dose

    42 IU BID for the six weeks

  • Experimental

    Oxytocin: High Dose

    84 IU BID for six weeks

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 6 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(14)

  1. Global Assessment of Functioning (GAF)

    Time frame · 6 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 of Illness (CGI-S)

    Time frame · 6 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 · 6 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 DualDisplayTM System (CMINDS®)

    Time frame · 6 weeks

    Registry description

    The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).

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

    Time frame · 6 weeks

    Registry description

    The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.

  6. Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame · 6 weeks

    Registry description

    The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.

  7. Hamilton-Anxiety Scale (HAM-A)

    Time frame · 6 weeks

    Registry description

    The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).

  8. Paranoid Thoughts Scale (PTS)

    Time frame · 6 weeks

    Registry description

    The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally).

  9. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame · 6 weeks

    Registry description

    The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence

  10. Childhood Trauma Questionnaire (CTQ)

    Time frame · 6 weeks

    Registry description

    The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect).

  11. Experience Close Relationships (ECR)

    Time frame · 6 weeks

    Registry description

    The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) .

  12. Arizona Sexual Experience Scale (ASEX)

    Time frame · 6 weeks

    Registry description

    The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time.

  13. Social Phobia Inventory (SPIN)

    Time frame · 6 weeks

    Registry description

    The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.

  14. Penn Emotion Recognition Test (ER-40)

    Time frame · 6 weeks

    Registry description

    The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity.

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· 6 weeks

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

GroupValue
All Participantsnot posted
Secondary and other outcome results(7)
Secondary outcome· 6 weeks

Global Assessment of Functioning (GAF)

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

Clinical Global Impression-Severity of Illness (CGI-S)

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

Clinical Global Impression-Global Improvement (CGI-I)

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

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

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

Calgary Depression Scale for Schizophrenia (CDSS)

GroupValue
All Participantsnot posted
Secondary outcome· 6 weeks

Hamilton-Anxiety Scale (HAM-A)

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 ParticipantsThe PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.0 / 00 / 00 / 0

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 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adult men or women, 21 years of age or older. * Meet DSM-IV criteria for Schizophrenia. * 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. * Must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks. * A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. * Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline. * Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. * Must be able to use nasal spray. * Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. Exclusion Criteria: * Are pregnant or are breastfeeding (negative pregnancy test at screening). * A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse. * Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study. * Are unsuitable in any way to participate in this study, in the opinion of the investigator. * Another current DSM-IV diagnosis other than Schizophrenia. Permitted: * Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.

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