SchizophreniaPhase 2NCT00663039
Effects of Oxytocin Nasal Spray on Social Affiliation
A Phase 2 study testing Oxytocin in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2015
- Phase
- Phase 2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male/Female subjects between ages of 18-64 years
- The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
- The presence of visuo-spatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
- Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder
- Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.
Who cannot join
- Subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
- Subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
- Medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
- Received any investigational drug in the preceding four weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments.
Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
Read the detailed description
The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects will be tested in two one-day studies carried out at least a month apart. Subjects will receive a 24 IU dose of intranasal oxytocin (or placebo) followed by a battery of cognitive/neurophysiological tests administered 50 minutes later completed over the next 155 minutes. A second dose of the drug (oxytocin or placebo) will be administered 2 hours after the 1st in order to maintain therapeutic plasma levels and to complete all testing.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, Placebo
- Keywords
- Schizophrenia, Eye movements, phenotype, biochemical, relatives
- 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 Pitocin, Syntocinon
24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)
PlaceboDrug
Single dose (plus a booster dose) drug probe study using intranasal placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin, then Placebo | Experimental | Participants first received 24IU of Oxytocin administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received placebo. Receives: Drug: Oxytocin |
| Placebo, then Oxytocin | Experimental | Participants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Affiliation Measured by Social Affiliative Role Play
In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).
Measured: 30 minutes
Secondary outcomes (8)
Hopkins Verbal Learning Test (HVLT)
HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first study day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.
Measured: 15 minutes
Trust Game
Participants competed in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds the participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive an portion of the total offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.
Measured: 20 minutes
RVIP Reaction Times
Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits
Measured: 25 minutes
Rapid Visual Information Processing Test (RVIP)
RVIP measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600ms; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits. There are a total of 48 target sequences during each test block. The number of correctly Identified target sequences or hits is recorded, as well as, false alarms (incorrectly identified target sequences) and reaction times.
Measured: 25 minutes
Brief Assessments of Cognition for Schizophrenia
The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer and provides a highly reliable measure of processing speed. There are nine symbols code 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches is the participants score. Scores range from 0-110.
Measured: 5 minutes
Brief Smell Identification Test
The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.
Measured: 5 minutes
Reading the Mind in the Eyes
A 30 item task presents a picture of a person's eyes and the participant is ask to determine the person's mental state from 4 multiple choice options.
Measured: 10 minutes
Facial Affect Recognition
This computer administered test includes 40 color photographs of four universal emotions (happy, sad, angry, and fearful) balanced for the posers gender, age, and ethnicity, including four low intensity and four high-intensity facial expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startOct 2009
- Primary completionJul 2015
- Study completionJul 2015
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 Maryland, BaltimoreThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- L E Hong, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663039
- Sponsor's protocol ID
- HP-00043595
- Other IDs
- P50MH082999
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2008
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin Nasal Spray on Social Affiliation
- ClinicalTrials.gov ID
- NCT00663039
- Acronym / sponsor ID
- HP-00043595
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Eye movements, phenotype, biochemical, relatives
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2009 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments.
Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
Detailed description
The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects will be tested in two one-day studies carried out at least a month apart. Subjects will receive a 24 IU dose of intranasal oxytocin (or placebo) followed by a battery of cognitive/neurophysiological tests administered 50 minutes later completed over the next 155 minutes. A second dose of the drug (oxytocin or placebo) will be administered 2 hours after the 1st in order to maintain therapeutic plasma levels and to complete all testing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin, then Placebo | Experimental | Drug: OxytocinParticipants first received 24IU of Oxytocin administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received placebo. |
| Placebo, then Oxytocin | Experimental | Drug: PlaceboParticipants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male/Female subjects between ages of 18-64 years
- The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
- The presence of visuo-spatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
- Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder
- Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.
Key exclusion criteria (4 listed)
- Subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
- Subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
- Medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
- Received any investigational drug in the preceding four weeks.
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: Pitocin, Syntocinon24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril) | Drug | Oxytocin, then Placebo |
| PlaceboSingle dose (plus a booster dose) drug probe study using intranasal placebo | Drug | Placebo, then Oxytocin |
Primary outcome
Social Affiliation Measured by Social Affiliative Role Play
Time frame: 30 minutes
In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).
8 secondary outcomes
Hopkins Verbal Learning Test (HVLT)
Time frame: 15 minutes
Trust Game
Time frame: 20 minutes
RVIP Reaction Times
Time frame: 25 minutes
Rapid Visual Information Processing Test (RVIP)
Time frame: 25 minutes
Brief Assessments of Cognition for Schizophrenia
Time frame: 5 minutes
Brief Smell Identification Test
Time frame: 5 minutes
Reading the Mind in the Eyes
Time frame: 10 minutes
Facial Affect Recognition
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
L E Hong, M.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Schizophrenia, run by University of Maryland, Baltimore 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 5 inclusion and 4 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 9 Sep 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2018). 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?
Social Affiliation Measured by Social Affiliative Role Play (time frame: 30 minutes). 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 Sep 2019.