Primary outcomeMean· 30 minutes
Social Affiliation Measured by Social Affiliative Role Play
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 4.026 | 0.656 |
| Placebo | 4.111 | 0.583 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEffects of Oxytocin Nasal Spray on Social Affiliation
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 27 participants (actual)
- Sponsor
- University of Maryland, Baltimore · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Oct 2009
- Primary completion
- Jul 2015
- Completion
- Jul 2015
- First posted
- 21 Apr 2008 (estimated)
- Last update posted
- 9 Sept 2019
- Conditions
- Schizophrenia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201220142016
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Oxytocin, then Placebo
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.
Experimental
Placebo, then Oxytocin
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Social Affiliation Measured by Social Affiliative Role Play
Time frame · 30 minutes
Registry description
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).
Secondary outcomes(8)
Hopkins Verbal Learning Test (HVLT)
Time frame · 15 minutes
Registry description
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.
Trust Game
Time frame · 20 minutes
Registry description
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.
RVIP Reaction Times
Time frame · 25 minutes
Registry description
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
Rapid Visual Information Processing Test (RVIP)
Time frame · 25 minutes
Registry description
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.
Brief Assessments of Cognition for Schizophrenia
Time frame · 5 minutes
Registry description
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.
Brief Smell Identification Test
Time frame · 5 minutes
Registry description
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.
Reading the Mind in the Eyes
Time frame · 10 minutes
Registry description
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.
Facial Affect Recognition
Time frame · 10 minutes
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 15 minutes
Hopkins Verbal Learning Test (HVLT)
| Group | Value (Number of correct responses) | Spread |
|---|---|---|
| Oxytocin | 6.19 | 2.23 |
| Placebo | 6.57 | 1.79 |
Secondary outcomeMean· 20 minutes
Trust Game
| Group | Value (Dollars) | Spread |
|---|---|---|
| Oxytocin | 112.5 | 60 |
| Placebo | 134.5 | 68.5 |
Secondary outcomeMean· 25 minutes
RVIP Reaction Times
| Group | Value (milliseconds) | Spread |
|---|---|---|
| Oxytocin | 563 | 103 |
| Placebo | 586 | 110 |
Secondary outcomeMean· 25 minutes
Rapid Visual Information Processing Test (RVIP)
| Group | Value (Number of responses) | Spread |
|---|---|---|
| Oxytocin | 16.40 | 8.58 |
| Placebo | 19.15 | 7.45 |
Secondary outcomeMean· 5 minutes
Brief Assessments of Cognition for Schizophrenia
| Group | Value (Number of correct responses) | Spread |
|---|---|---|
| Oxytocin | 45.6 | 13.8 |
| Placebo | 47.7 | 14.3 |
Secondary outcomeMean· 5 minutes
Brief Smell Identification Test
| Group | Value (Number of correct responses) | Spread |
|---|---|---|
| Oxytocin | 10.06 | 1.53 |
| Placebo | 10.14 | 1.10 |
Secondary outcomeMean· 10 minutes
Reading the Mind in the Eyes
| Group | Value (Number of correct responses) | Spread |
|---|---|---|
| Oxytocin | 24.40 | 6.06 |
| Placebo | 24.54 | 5.78 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinOxytocin administered on study | 0 / 19 | 0 / 19 | 3 / 19 |
| PlaceboPlacebo administered on study day | 0 / 18 | 0 / 18 | 0 / 18 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 64 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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