Trial · NCT01752712
Oxytocin and CBSST for People With Schizophrenia
NCT01752712, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2017-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxytocin and CBSST for People With Schizophrenia. Trials, record NCT01752712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01752712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxytocin and CBSST for People With Schizophrenia
- NCT number
- NCT01752712
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 83 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- CBSST + Oxytocin, CBSST + Placebo
- First posted
- 2012-12-19
- Last updated
- 2019-09-25
- Results first posted
- 2017-10-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Birchwood Social Function Scale (BSFS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: "Social Engagement Withdrawal" range from 0-15; Section 2: "Interpersonal Communication/Relationships" ranges from 0-30; Section 3: "Prosocial Activities" range is 0-66; Section 4: "Recreation" ranges from 0-48; Section 5: "Independence (Performance)" ranges from 0-39; Section 6: "Independence (Competence)" ranges from 0-39; and Section 7: "Occupation/Employment" ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating. |
| Secondary | Defeatist Performance Attitudes Scale (DPAS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Agree Totally" to "7=Disagree Totally". Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude. |
| Secondary | Asocial Belief Scale (ABS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs. |
| Secondary | Schedule for Assessment of Negative Symptoms (SANS) Total Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. |
| Secondary | Brief Psychiatric Rating Scale (BPRS) Total Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. |
| Secondary | Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Birchwood Social Function Scale (BSFS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a BSFS assessment were analyzed at each study time point. | units on a scale | MEAN |
| SECONDARY | Defeatist Performance Attitudes Scale (DPAS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a DPAS assessment were analyzed at each study time point. | units on a scale | MEAN |
| SECONDARY | Asocial Belief Scale (ABS) Total Score | Treatment weeks 0, 12, and 24, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a ABS assessment were analyzed at each study time point. | units on a scale | MEAN |
| SECONDARY | Schedule for Assessment of Negative Symptoms (SANS) Total Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a SANS assessment were analyzed at each study time point. | units on a scale | MEAN |
| SECONDARY | Brief Psychiatric Rating Scale (BPRS) Total Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point. | units on a scale | MEAN |
| SECONDARY | Brief Psychiatric Rating Scale (BPRS) Psychosis Score | Every 4 weeks during the treatment phase, plus follow-up week 36 | Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Oxytocin | Treatment Week 0 | 120 | Standard Deviation 23.1 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Placebo | Treatment Week 0 | 115.8 | Standard Deviation 21.4 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Oxytocin | Treatment Week 12 | 120.8 | Standard Deviation 21.9 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Placebo | Treatment Week 12 | 127 | Standard Deviation 21.8 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Oxytocin | Treatment Week 24 | 125.3 | Standard Deviation 20.3 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Placebo | Treatment Week 24 | 126.4 | Standard Deviation 17.4 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Oxytocin | Follow-Up Week 36 | 124 | Standard Deviation 20.2 | units on a scale |
| Birchwood Social Function Scale (BSFS) Total Score | CBSST + Placebo | Follow-Up Week 36 | 125.8 | Standard Deviation 21.4 | units on a scale |
| Defeatist Performance Attitudes Scale (DPAS) Total Score | CBSST + Oxytocin | Treatment Week 0 | 68.55 | Standard Deviation 19.23 | units on a scale |
| Defeatist Performance Attitudes Scale (DPAS) Total Score | CBSST + Placebo | Treatment Week 0 | 67.87 | Standard Deviation 15.31 | units on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CBSST + Oxytocin | 31 | |
| Overall Study | STARTED | CBSST + Placebo | 31 | |
| Overall Study | COMPLETED | CBSST + Oxytocin | 22 | |
| Overall Study | COMPLETED | CBSST + Placebo | 21 | |
| Overall Study | NOT COMPLETED | CBSST + Oxytocin | 9 | |
| Overall Study | NOT COMPLETED | CBSST + Placebo | 10 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | General disorders | CBSST + Oxytocin | 0 | 31 | 0 |
| other | Dry mouth | General disorders | CBSST + Placebo | 2 | 31 | 2 |
| other | Dizziness | Ear and labyrinth disorders | CBSST + Oxytocin | 0 | 31 | 0 |
| other | Dizziness | Ear and labyrinth disorders | CBSST + Placebo | 1 | 31 | 1 |
| other | Nasal irritation | General disorders | CBSST + Oxytocin | 1 | 31 | 1 |
| other | Nasal irritation | General disorders | CBSST + Placebo | 1 | 31 | 1 |
| other | Headache | General disorders | CBSST + Oxytocin | 0 | 31 | 0 |
| other | Headache | General disorders | CBSST + Placebo | 1 | 31 | 3 |
| other | Anxiety | Psychiatric disorders | CBSST + Oxytocin | 2 | 31 | 3 |
| other | Anxiety | Psychiatric disorders | CBSST + Placebo | 0 | 31 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CBSST + Oxytocin | ||
| Total, all-cause mortality | CBSST + Placebo | ||
| Total, other adverse events | CBSST + Oxytocin | 3 | 31 |
| Total, other adverse events | CBSST + Placebo | 5 | 31 |
| Total, serious adverse events | CBSST + Oxytocin | 1 | 31 |
| Total, serious adverse events | CBSST + Placebo | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33783399 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CBSST + Oxytocin vs CBSST + Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01752712
GET https://conductscience.org/api/trials/v1/NCT01752712/results?page=2