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SchizophreniaEarly Phase 1OTNCT02577575

Adult Oxytocin Study

A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Schizophrenia and Oxytocin, run by University of California, San Francisco at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia, Oxytocin, Social Cognition
What is being tested?
Oxytocin and Saline Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesUnited States
Study dates
Aug 2010to Nov 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 to 65 years of age
  • English Speaking
  • Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder.
  • No or at most only minor changes to medications in the past week
  • Able to use nasal spray
  • Must be capable of providing informed consent
Show all 12Show fewer
  • 18 to 65 years of age
  • Clinically stable
  • No diagnosis of mental disorder according to DSM-IV TR.
  • Able to use nasal spray
  • Must be capable of providing informed consent
  • English Speaking

Who cannot join

  • Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
  • A current DSM-IV diagnosis of any disorder other than schizophrenia
  • Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), congestion or sinus problems) that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.

Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

Read more

Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.

Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.

Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.

Being tested
Oxytocin, Saline Nasal Spray
Keywords
Oxytocin, Syntocinon, Social Cognition, Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Also called Syntocinon

    40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

  • Saline Nasal SprayDrug

    Also called Placebo

    40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Study groups in NCT02577575
Study groupRoleWhat they receive
OxytocinExperimental40 IU Oxytocin
Receives: Drug: Oxytocin
Saline Nasal SprayPlacebo comparatorPlacebo Comparator
Receives: Drug: Saline Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in social cognition task performance

    The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.

    Measured: 2-days at least 1-week apart

Secondary outcomes (8)

  1. Pre-morbid IQ Questionnaire (AmNART)

    The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal intelligence quotient (IQ) in adults. Participants are shown 45 words one at a time and are asked to read the word aloud. The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct.

    Measured: 1 day

  2. Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire

    The ECR is used to evaluate the construct of adult attachment. The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure. Participants rank each item using a 7-point likert scale.

    Measured: 1 day

  3. Childhood Trauma Questionnaire (CTQ)

    The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other. The scale determines and assesses an individual's understanding of their childhood trauma, if applicable.

    Measured: 1 day

  4. Emotional Quotient Scale (EQS)

    The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults. Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree).

    Measured: 1 day

  5. Kinsey Scale

    The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).

    Measured: 1 day

  6. Change in Working Memory capacity

    This task determines a participant's working memory capacity using the University of Maryland Letter Number Span Assessment. This asks 24 questions of increasing working memory difficulty and the total correct is calculated. Investigators will measure the change in the total correct between oxytocin and placebo days.

    Measured: 2-days at least 1-week apart

  7. Change in Auditory Perception correctness

    The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the total correct responses between oxytocin and placebo days.

    Measured: 2-days at least 1-week apart

  8. Change in Auditory Perception reaction time

    The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the reaction time between oxytocin and placebo days.

    Measured: 2-days at least 1-week apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577575
Sponsor's protocol ID
10-01508
Acronym
OT
Status last verified
May 2019
First submitted
29 Sep 2015
Last updated
21 May 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Schizophrenia and Oxytocin, run by University of California, San Francisco 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 21 May 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Improvement in social cognition task performance (time frame: 2-days at least 1-week apart). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577575.

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 21 May 2019.

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