SchizophreniaNCT01621737
Antipsychotic Effects of Oxytocin
A study testing Oxytocin in people with Schizophrenia, run by University of California, San Diego at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Dec 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Irvine
Irvine, California, 92037
University of California, San Diego
San Diego, California, 92103
About this study
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.
Read the detailed description
This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.
The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, 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.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin: Low Dose | Experimental | 42 IU BID for the six weeks Receives: Drug: Oxytocin |
| Oxytocin: High Dose | Experimental | 84 IU BID for six weeks Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Not described Receives: 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 Endpoint
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: 6 weeks
Secondary outcomes (14)
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: 6 weeks
Clinical Global Impression-Severity of Illness (CGI-S)
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: 6 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: 6 weeks
Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)
The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).
Measured: 6 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.
Measured: 6 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.
Measured: 6 weeks
Hamilton-Anxiety Scale (HAM-A)
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).
Measured: 6 weeks
Paranoid Thoughts Scale (PTS)
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).
Measured: 6 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
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
Measured: 6 weeks
Childhood Trauma Questionnaire (CTQ)
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).
Measured: 6 weeks
Experience Close Relationships (ECR)
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) .
Measured: 6 weeks
Arizona Sexual Experience Scale (ASEX)
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.
Measured: 6 weeks
Social Phobia Inventory (SPIN)
The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.
Measured: 6 weeks
Penn Emotion Recognition Test (ER-40)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2018
- Study completionDec 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Feifel, University of California, San Diego
- Investigators
- David Feifel, MD, Ph.D, Principal investigator, UCSDSteven Potkin, MD, Principal investigator, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621737
- Sponsor's protocol ID
- 111017
- Other IDs
- R34MH091285
- Status last verified
- Nov 2019
- First submitted
- 3 Jun 2012
- Last updated
- 19 Nov 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipsychotic Effects of Oxytocin
- ClinicalTrials.gov ID
- NCT01621737
- Acronym / sponsor ID
- 111017
- Conditions
- Schizophrenia
- Keywords
- oxytocin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break in funding
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 19 Nov 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 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.
Detailed description
This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.
The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin: Low Dose | Experimental | Drug: Oxytocin42 IU BID for the six weeks |
| Oxytocin: High Dose | Experimental | Drug: Oxytocin84 IU BID for six weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 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 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 |
|---|---|---|
| Oxytocin42 IU BID for six weeks | Drug | Oxytocin: Low Dose |
| Oxytocin84 IU BID for six weeks | Drug | Oxytocin: High Dose |
| PlaceboVehicle placebo | Drug | Placebo |
Primary outcome
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
Time frame: 6 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.
14 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: 6 weeks
Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: 6 weeks
Clinical Global Impression-Global Improvement (CGI-I)
Time frame: 6 weeks
Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)
Time frame: 6 weeks
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Time frame: 6 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: 6 weeks
Hamilton-Anxiety Scale (HAM-A)
Time frame: 6 weeks
Paranoid Thoughts Scale (PTS)
Time frame: 6 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 6 weeks
Childhood Trauma Questionnaire (CTQ)
Time frame: 6 weeks
Experience Close Relationships (ECR)
Time frame: 6 weeks
Arizona Sexual Experience Scale (ASEX)
Time frame: 6 weeks
Social Phobia Inventory (SPIN)
Time frame: 6 weeks
Penn Emotion Recognition Test (ER-40)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
David Feifel, MD, Ph.D principal investigator
UCSD
Steven Potkin, MD principal investigator
UCI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Schizophrenia, run by University of California, San Diego at 2 sites 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 7 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 19 Nov 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 Endpoint (time frame: 6 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 19 Nov 2019.