Trial · NCT00291226
Glycine vs Placebo for the Schizophrenia Prodrome
NCT00291226, Phase 2, Phase 3, Completed, Yale University; results first posted 2016-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glycine vs Placebo for the Schizophrenia Prodrome. Trials, record NCT00291226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00291226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glycine vs Placebo for the Schizophrenia Prodrome
- NCT number
- NCT00291226
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Schizophrenia Prodrome
- Interventions
- Glycine, Placebo
- First posted
- 2006-02-13
- Last updated
- 2020-04-02
- Results first posted
- 2016-12-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Scale of Prodromal Symptoms Total Score | Baseline | Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline. |
| Primary | Change in Scale of Prodromal Symptoms Total Score | Change from Baseline at 8 Weeks | Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Scale of Prodromal Symptoms Total Score | Baseline | units on a scale | MEAN | |
| PRIMARY | Change in Scale of Prodromal Symptoms Total Score | Change from Baseline at 8 Weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Scale of Prodromal Symptoms Total Score | Glycine | 37.8 | Standard Deviation 15.3 | units on a scale | |
| Scale of Prodromal Symptoms Total Score | Placebo Group | 37.5 | Standard Deviation 10.0 | units on a scale | |
| Change in Scale of Prodromal Symptoms Total Score | Glycine | -5.8 | Standard Deviation 8.1 | units on a scale | |
| Change in Scale of Prodromal Symptoms Total Score | Placebo Group | 4.5 | Standard Deviation 9.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glycine | 4 | |
| Overall Study | STARTED | Placebo Group | 4 | |
| Overall Study | COMPLETED | Glycine | 3 | |
| Overall Study | COMPLETED | Placebo Group | 3 | |
| Overall Study | NOT COMPLETED | Glycine | 1 | |
| Overall Study | NOT COMPLETED | Placebo Group | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | Irritability | Psychiatric disorders | Glycine | 0 | 4 | 0 |
| other | Irritability | Psychiatric disorders | Placebo Group | 1 | 4 | 1 |
| other | Sedation | Psychiatric disorders | Glycine | 0 | 4 | 0 |
| other | Sedation | Psychiatric disorders | Placebo Group | 2 | 4 | 2 |
| other | Orgasm Dysfunction | Reproductive system and breast disorders | Glycine | 1 | 4 | 1 |
| other | Orgasm Dysfunction | Reproductive system and breast disorders | Placebo Group | 0 | 4 | 0 |
| other | Disturbed Sleep | General disorders | Glycine | 0 | 4 | 0 |
| other | Disturbed Sleep | General disorders | Placebo Group | 2 | 4 | 2 |
| other | Malaise | General disorders | Glycine | 0 | 4 | 0 |
| other | Malaise | General disorders | Placebo Group | 1 | 4 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glycine | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Glycine | 1 | 4 |
| Total, other adverse events | Placebo Group | 4 | 4 |
| Total, serious adverse events | Glycine | 0 | 4 |
| Total, serious adverse events | Placebo Group | 0 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23089076 | 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 |
|---|
| Glycine vs Placebo Group: 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/NCT00291226
GET https://conductscience.org/api/trials/v1/NCT00291226/registered