Trial Outcomes & Findings for Oxytocin and Social Cognition in Schizophrenia (NCT NCT00884897)
NCT ID: NCT00884897
Last Updated: 2019-10-02
Results Overview
Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
participants are assessed at baseline and end point
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Oxytocin
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID
|
Placebo
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin and Social Cognition in Schizophrenia
Baseline characteristics by cohort
| Measure |
Oxytocin
n=13 Participants
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID
|
Placebo
n=15 Participants
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.74 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
35.07 Years
STANDARD_DEVIATION 8.21 • n=7 Participants
|
39.6 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: participants are assessed at baseline and end pointMayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.
Outcome measures
| Measure |
Oxytocin
n=13 Participants
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID
|
Placebo
n=15 Participants
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID
|
|---|---|---|
|
To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients
Understanding Emotions (Baseline)
|
82.2 units on a scale
Standard Deviation 12.4
|
77.9 units on a scale
Standard Deviation 9.8
|
|
To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients
Understanding Emotions (Endpoint)
|
76.7 units on a scale
Standard Deviation 9.2
|
84.3 units on a scale
Standard Deviation 10.4
|
|
To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients
Managing Emotions (Baseline)
|
87.1 units on a scale
Standard Deviation 10.0
|
77.9 units on a scale
Standard Deviation 9.8
|
|
To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients
Managing Emotions (Endpoint)
|
76.7 units on a scale
Standard Deviation 9.2
|
84.3 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Outcomes are compared between Baseline and endpointTo determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.
Outcome measures
| Measure |
Oxytocin
n=13 Participants
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID
|
Placebo
n=15 Participants
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID
|
|---|---|---|
|
To Determine Whether OT Improves Measures of Social Anxiety.
Baseline
|
30.1 units on a scale
Standard Deviation 14.4
|
33.9 units on a scale
Standard Deviation 17.8
|
|
To Determine Whether OT Improves Measures of Social Anxiety.
4 Weeks (Endpoint)
|
26.4 units on a scale
Standard Deviation 12.0
|
26.1 units on a scale
Standard Deviation 14.2
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=13 participants at risk
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin: Oxytocin given as 20 IU BID
|
Placebo
n=15 participants at risk
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo: Placebo given as 20 IU BID
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13
|
0.00%
0/15
|
|
General disorders
Abdominal pain
|
23.1%
3/13
|
20.0%
3/15
|
|
General disorders
Anorexia
|
0.00%
0/13
|
6.7%
1/15
|
|
General disorders
Constipation
|
7.7%
1/13
|
6.7%
1/15
|
|
General disorders
Diarrhea
|
7.7%
1/13
|
13.3%
2/15
|
|
General disorders
Dizziness
|
7.7%
1/13
|
13.3%
2/15
|
|
General disorders
Dry mouth
|
7.7%
1/13
|
20.0%
3/15
|
|
General disorders
Fever
|
7.7%
1/13
|
0.00%
0/15
|
|
General disorders
Headache
|
7.7%
1/13
|
26.7%
4/15
|
|
General disorders
Insomnia
|
23.1%
3/13
|
26.7%
4/15
|
|
General disorders
Malaise
|
15.4%
2/13
|
6.7%
1/15
|
|
General disorders
Nausea
|
30.8%
4/13
|
6.7%
1/15
|
|
General disorders
Restlessness
|
30.8%
4/13
|
26.7%
4/15
|
|
General disorders
Salivation
|
23.1%
3/13
|
6.7%
1/15
|
|
General disorders
Sedation
|
23.1%
3/13
|
6.7%
1/15
|
|
General disorders
Sore throat
|
0.00%
0/13
|
13.3%
2/15
|
|
General disorders
Stiffness
|
15.4%
2/13
|
6.7%
1/15
|
|
General disorders
Tinnitus
|
0.00%
0/13
|
13.3%
2/15
|
|
General disorders
Tremor
|
15.4%
2/13
|
13.3%
2/15
|
|
General disorders
Urticaria
|
0.00%
0/13
|
6.7%
1/15
|
Additional Information
Deanna L. Kelly Pharm.D., BCPP
Maryland Psychiatric Research Center
Phone: 410-402-96860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place