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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Oxytocin Add on Study for Stable Schizophrenic Patients

Short name Oxytocin

NCTNCT00506909 (opens ClinicalTrials.gov in a new tab)Other idOxytocin Schizophrenia
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
21 participants (actual)
Sponsor
David Feifel · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Mar 2008
Primary completion
Mar 2014
Completion
Mar 2014
First posted
25 Jul 2007 (estimated)
Last update posted
25 Sept 2019
Conditions
Schizophrenia

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008201020122014
  1. N/A

    Oxytocin

    NCT00506909

    Mar 2008 to Mar 2014

    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
  • PlaceboDrug

Arms2

  • Experimental

    Group 1

    Group 1: 20 IU BID for the first week, 40IU BID for the following two weeks, 1 week washout, 3 week placebo trial.

  • Experimental

    Group 2

    Group 2: 3 week placebo trial, 1 week washout, 20 IU BID for the first week, 40IU BID for the following two weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Score in the Positive and Negative Syndrome Scale (PANSS)

    Time frame · performed at each visit (weekly)

Secondary outcomes(12)

  1. Clinical Global Impression-Severity of Illness

    Time frame · performed at each visit (weekly)

  2. Calgary Depression Scale for Schizophrenia

    Time frame · performed at each visit (weekly)

  3. Clinical Global Impression-Global Improvement

    Time frame · Performed at Visits 2-8 (weekly)

  4. Global Assessment of Functioning

    Time frame · performed at each visit (weekly)

  5. Hamilton Anxiety Scale

    Time frame · performed at each visit (weekly)

  6. Peabody Picture Vocabulary Test

    Time frame · Visit 1 only

  7. Letter Number Sequencing Memory Test

    Time frame · Visits 1, 4, and 8 (every 4 weeks)

  8. Reading Trust in the Eyes Test (RTET)

    Time frame · Visits 1, 4, 5 and 8 (every 4 weeks)

  9. California Verbal Learning Test-Second Edition

    Time frame · Visits 1, 4, and 8 (every 4 weeks)

  10. Profile of Mood States

    Time frame · Visits 1 and 5 (first visit and 5 weeks later)

  11. Paranoid Thought Scale

    Time frame · Visits 1-8 (weekly)

  12. Arizona Sexual Experience Scale (ASEX)

    Time frame · Visits 1-8 (weekly)

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· performed at each visit (weekly)

Total Score in the Positive and Negative Syndrome Scale (PANSS)

GroupValue
All Participantsnot posted
Secondary and other outcome results(7)
Secondary outcome· performed at each visit (weekly)

Clinical Global Impression-Severity of Illness

GroupValue
All Participantsnot posted
Secondary outcome· performed at each visit (weekly)

Calgary Depression Scale for Schizophrenia

GroupValue
All Participantsnot posted
Secondary outcome· Performed at Visits 2-8 (weekly)

Clinical Global Impression-Global Improvement

GroupValue
All Participantsnot posted
Secondary outcome· performed at each visit (weekly)

Global Assessment of Functioning

GroupValue
All Participantsnot posted
Secondary outcome· performed at each visit (weekly)

Hamilton Anxiety Scale

GroupValue
All Participantsnot posted
Secondary outcome· Visit 1 only

Peabody Picture Vocabulary Test

GroupValue
All Participantsnot posted
Secondary outcome· Visits 1, 4, and 8 (every 4 weeks)

Letter Number Sequencing Memory Test

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2012

4 results

Adjunctive intranasal oxytocin improves verbal memory in people with schizophrenia.

Feifel et al. 2012Schizophrenia researchcited by 92

PMID 22682705DOI 10.1016/j.schres.2012.05.018PUB-22682705

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2010

4 results

Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients.

Feifel et al. 2010Biological psychiatrycited by 243

PMID 20615494DOI 10.1016/j.biopsych.2010.04.039PUB-20615494

Full text at the publisher4 results
Publisher pageSee results (4)

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 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. 5. 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. 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: Subjects will be excluded from the study of they meet any of the following 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 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.

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