Primary outcomeMean· 6 weeks
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
| Group | Value (number of correct responses) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 7.25 | .89 |
| Intranasal Spray Without Oxytocin | 6.67 | 1.86 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataOxytocin Treatment of Schizophrenia
Short name OTS
NCTNCT01028677 (opens ClinicalTrials.gov in a new tab)Other id07-0879
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 17 participants (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Nov 2009
- Primary completion
- Mar 2011
- Completion
- Mar 2011
- First posted
- 9 Dec 2009 (estimated)
- Last update posted
- 18 Apr 2017
- Conditions
- Paranoia · Schizophrenia · Schizoaffective Disorder
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2009201020112012
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia. Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia. Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).
Interventions
- intranasal spray with oxytocinDrug
- nasal spray without oxytocinOther
Arms2
Experimental
intranasal spray with oxytocin
Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks
Placebo comparator
intranasal spray without oxytocin
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
Primary outcomes5
Outcomes the sponsor listed as primary.
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Time frame · 6 weeks
Registry description
The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, \& Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified). The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity.
Theory of Mind as Measured by the Eyes Test at 6 Weeks
Time frame · 6 weeks
Registry description
The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, \& Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).
Theory of Mind as Measured by the Brune Test at 6 Weeks
Time frame · 6 weeks
Registry description
In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant's interpretations of the characters' beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.
Social Perception as Measured by the Trustworthiness Task at 6 Weeks
Time frame · 6 weeks
Registry description
The Trustworthiness Task (Adolphs, Tranel, \& Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.'s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
Time frame · 6 weeks
Registry description
The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response. Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35
Secondary outcomes(1)
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks
Time frame · 6 weeks
Registry description
The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome). Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 6 weeks
Theory of Mind as Measured by the Eyes Test at 6 Weeks
| Group | Value (correct responses) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 22.25 | 5.29 |
| Intranasal Spray Without Oxytocin | 22.17 | 7.83 |
Primary outcomeMean· 6 weeks
Theory of Mind as Measured by the Brune Test at 6 Weeks
| Group | Value (correct responses) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 21.13 | 1.36 |
| Intranasal Spray Without Oxytocin | 22.00 | 1.27 |
Primary outcomeMean· 6 weeks
Social Perception as Measured by the Trustworthiness Task at 6 Weeks
| Group | Value (rating on a scale) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 1.88 | 40.98 |
| Intranasal Spray Without Oxytocin | 11.33 | 34.23 |
Primary outcomeMean· 6 weeks
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks
| Group | Value (rating on a scale) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 88.00 | 13.71 |
| Intranasal Spray Without Oxytocin | 87.00 | 8.57 |
Secondary and other outcome results(1)
Secondary outcomeMean· 6 weeks
Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks
| Group | Value (rating on a scale) | Spread |
|---|---|---|
| Intranasal Spray With Oxytocin | 14.00 | 3.34 |
| Intranasal Spray Without Oxytocin | 18.50 | 6.22 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intranasal Spray With OxytocinTwice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks | – | 0 / 10 | 1 / 10 |
| Intranasal Spray Without OxytocinTwice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks. nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks | – | 0 / 7 | 0 / 7 |
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 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.
* Scoring \> or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score \> or equal to 60: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.
Exclusion Criteria:
* Low literacy as indicated by an inability to read and understand the consent form.
* Dependence on substances other than tobacco or caffeine.
* Positive urine drug screen for illegal substances or drugs that have not been prescribed.
* Debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion).
* Major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the PI.
* Pregnancy, breast-feeding.
* Having given birth in the past 6 months or breast-feeding in the past 3 months.
* Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.
* Abnormalities found during medical evaluation will be grounds for exclusion although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.
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