SchizophreniaPhase 1DOSNCT02302209
Dyad Oxytocin Study (DOS)
A Phase 1 study testing Oxytocin in people with Schizophrenia and Autism Spectrum Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Autism Spectrum Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Oct 2017
- Phase
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:
- Age between 18 and 75 years old
- Must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient
- Between the ages of 14 and 45.
- Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS).
- Patients must be clinically stable
Show all 14Show fewer
- No or minor changes to medications in the past week
- Patients must have a primary caregiver
- Between the ages of 14 and 45
- Healthy control must have a primary caregiver
- Inclusion criteria for patients with autism spectrum disorder
- Between the ages of 14 and 45
- Patient must have a primary caregiver
- Patients must have a diagnosis of an autism spectrum disorder (ASD) (autism or Asperger's disorder), pervasive developmental disorder (PDD) or pervasive developmental disorder - not otherwise specified (PDD-NOS).
Who cannot join
- Female caregivers that state that they are pregnant or have a positive urine pregnancy test
- Caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
- Caregivers with significant psychiatric, neurologic, or medical illness
- Healthy controls with history of psychiatric or neurological illness
- Exclusion criteria for patients with an autism spectrum disorder:
- Patients with an Intelligence Quotient (IQ) lower than 75
- Patients with severe brain trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Effects of Oxytocin on Familial Interactions
The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.
- Conditions
- Schizophrenia, Autism Spectrum Disorder
- Being tested
- Oxytocin, Placebo Comparator
- Keywords
- oxytocin, schizophrenia, autism spectrum disorder
- Medical subject headings
- Schizophrenia, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocin
Placebo ComparatorOther
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 40 IU Oxytocin Intranasal Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Saline Nasal Spray Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Negative Expressed Emotion
We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.
Measured: Continuously for 4 hours after drug adimistration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startApr 2011
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Josh D Woolley, MD/PhD, Principal investigator, UC San Francisco and SFVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302209
- Sponsor's protocol ID
- 10-04286
- Acronym
- DOS
- Status last verified
- May 2019
- First submitted
- 24 Nov 2014
- Last updated
- 21 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Familial Interactions
- ClinicalTrials.gov ID
- NCT02302209
- Acronym / sponsor ID
- DOS / 10-04286
- Conditions
- Schizophrenia, Autism Spectrum Disorder
- Keywords
- oxytocin, schizophrenia, autism spectrum disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin40 IU Oxytocin Intranasal |
| Placebo | Placebo comparator | Other: Placebo ComparatorSaline Nasal Spray |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:
- Age between 18 and 75 years old
- Must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient
- Between the ages of 14 and 45.
- Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS).
Key exclusion criteria (7 listed)
- Female caregivers that state that they are pregnant or have a positive urine pregnancy test
- Caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
- Caregivers with significant psychiatric, neurologic, or medical illness
- Healthy controls with history of psychiatric or neurological illness
- Exclusion criteria for patients with an autism spectrum disorder:
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 |
|---|---|---|
| OxytocinAlso: Syntocin | Drug | Oxytocin |
| Placebo Comparator | Other | Placebo |
Primary outcome
Change in Negative Expressed Emotion
Time frame: Continuously for 4 hours after drug adimistration
We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Schizophrenia
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingObservational study
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Schizophrenia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
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.
Josh D Woolley, MD/PhD principal investigator
UC San Francisco and SFVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Schizophrenia and Autism Spectrum Disorder, run by University of California, San Francisco 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 14 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: 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Negative Expressed Emotion (time frame: Continuously for 4 hours after drug adimistration). 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 21 May 2019.