SchizophreniaNCT02144155
Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia
A study testing Oxytocin: 24IU - 168 IU in people with Schizophrenia, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin: 24IU - 168 IU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women, 18 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 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.
- 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.
- Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;
Show all 9Show fewer
- 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.
Who cannot join
- 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, primary DSM-IV diagnosis other than Schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Center - Hillcrest
San Diego, California, 92103
About this study
Official title: Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia
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.
Read the detailed description
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin: 24IU - 168 IU, Placebo
- Keywords
- Oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin: 24IU - 168 IUDrug
Oxytocin: 24IU - 168 IU
PlaceboDrug
placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin: 24 IU - 168 IU | Experimental | Oxytocin twice daily for 3 weeks Receives: Drug: Oxytocin: 24IU - 168 IU |
| Vehicle placebo | Sham comparator | Placebo for 3 weeks Receives: Drug: Oxytocin: 24IU - 168 IU; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
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.
Measured: baseline and 28 weeks
Secondary outcomes (5)
Global Assessment of Functioning (GAF)
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).
Measured: 28 weeks
Clinical Global Impression-Severity
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).
Measured: 28 Weeks
Clinical Global Impression-Global Improvement (CGI-I)
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).
Measured: 28 Weeks
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
Measured: 28 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Break in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144155
- Sponsor's protocol ID
- 120005
- Status last verified
- Dec 2019
- First submitted
- 19 May 2014
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02144155
- Acronym / sponsor ID
- 120005
- Conditions
- Schizophrenia
- Keywords
- Oxytocin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break in funding
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin: 24 IU - 168 IU | Experimental | Drug: Oxytocin: 24IU - 168 IUOxytocin twice daily for 3 weeks |
| Vehicle placebo | Sham comparator | Drug: Oxytocin: 24IU - 168 IU, Drug: PlaceboPlacebo for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men or women, 18 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 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.
- 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.
Key exclusion criteria (5 listed)
- 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, primary DSM-IV diagnosis other than Schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin: 24IU - 168 IUOxytocin: 24IU - 168 IU | Drug | Oxytocin: 24 IU - 168 IU, Vehicle placebo |
| Placeboplacebo drug | Drug | Vehicle placebo |
Primary outcome
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
Time frame: baseline and 28 weeks
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.
5 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: 28 weeks
Clinical Global Impression-Severity
Time frame: 28 Weeks
Clinical Global Impression-Global Improvement (CGI-I)
Time frame: 28 Weeks
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
Time frame: 28 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Time frame: 28 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin: 24IU - 168 IU in people with Schizophrenia, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks (time frame: baseline and 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.