Trial · NCT03790345
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
NCT03790345, Phase 2, Phase 3, Unknown, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics. Trials, record NCT03790345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03790345
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
- NCT number
- NCT03790345
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 45 participants, estimated
- Lead sponsor
- Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
- Conditions
- Schizophrenia, Drug Induced Movement Disorder, Unspecified, Oxidative Stress
- Interventions
- Pyridoxine, Cobalamin, Placebo Oral Tablet
- First posted
- 2018-12-31
- Last updated
- 2019-12-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Simpson-Angus Extrapyramidal Symptoms Scale (SAS) scores | Baseline and 12 weeks | 10-item rating scale to assess extrapyramidal symptoms; each item is scored 0-4, yielding a total between 0 and 40. |
| Primary | Change in the Barnes Akathisia Rating Scale (BAS, BARS) scores | Baseline and 12 weeks | Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 to 9. The Global Clinical Assessment of Akathisia uses a 5-point scale ranging from 0 - 4. |
| Primary | Change in the Abnormal Involuntary Movement Scale (AIMS) scores | Baseline and 12 weeks | 10-item rating scale to assess involuntary movements; items are rated on a five-point scale of severity from 0-4, yielding a total between 0 and 40. |
| Secondary | Change in the Brief Psychiatry Rating Scale (BPRS) scores | Baseline and 12 weeks | 18-item rating scale to assess changes in psychopathology; each item is scored 0-6, yielding a total between 0 and 40. |
| Secondary | Change in Plasma Glutathione (GSH) | Baseline and 12 weeks | GSH in ng/mL |
| Secondary | Change in serum level of Nitrite | Baseline and 12 weeks | Nitrite in nanomole/mililiter |
| Secondary | Change in serum level of Thiobarbituric acid reactive substances (TBARS) | Baseline and 12 weeks | TBARS in mmol of malonaldehyde/mL |
| Secondary | Change in serum level of Interleukin 1 β (IL-1β) | Baseline and 12 weeks | IL-1β in pg/mL |
| Secondary | Change in serum level of Interleukin-4 | Baseline and 12 weeks | IL-4 in pg/mL |
| Secondary | Change in serum level of Interferon gamma (IFNγ) | Baseline and 12 weeks | IFNγ in pg/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03790345
GET https://conductscience.org/api/trials/v1/NCT03790345/registered