Trial · NCT03210480
SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)
NCT03210480, Phase 4, Terminated, Aziende Chimiche Riunite Angelini Francesco S.p.A
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SALT Study (Switching to the Administration of Lithium Slow -Release Treatment). Trials, record NCT03210480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03210480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)
- NCT number
- NCT03210480
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 85 participants, actual
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Conditions
- Bipolar Disorder
- Interventions
- Lithium sulphate prolonged-release 660 mg, Lithium carbonate immediate-release 150 mg and 300 mg
- First posted
- 2017-07-07
- Last updated
- 2020-01-10
- Other registries' IDs
- eudract:2016-001714-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale | Baseline - Week 1 | Proportion of patients with an improvement in tremor assessed by the change from baseline of item 2.5 in UKU side-effect rating scale after 1-week treatment period. |
| Secondary | Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale | Baseline - Weeks 4 and 12 | Proportion of patients with an improvement in tremor assessed by the change from baseline of item 2.5 in UKU side-effect rating scale after 4- and 12-week treatment period. |
| Secondary | Change of item 3.8 in Udvalg for Kliniske Undersøgelser (UKU) scale | Baseline - Weeks 1, 4 and 12 | Proportion of patients with a change from baseline of item 3.8 in UKU side-effect rating scale after 1-, 4- and 12-week treatment period. |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline - Weeks 1, 4 and 12 | Change from baseline of total score in MADRS scale after 1-, 4- and 12-week treatment period. |
| Secondary | Change in Young Mania Rating Scale (YMRS) | Baseline - Weeks 1, 4 and 12 | Change from baseline of total score in YMRS scale after 1-, 4- and 12-week treatment period. |
| Secondary | Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scale | Baseline - Weeks 1 and 12 | Change from baseline in each sub-scale of TSQM after 1- and 12-week treatment period. |
| Secondary | Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Baseline - Weeks 1 and 12 | Change from baseline in Q-LES-Q-SF after 1- and 12-week treatment period. |
| Secondary | Change in Clinical Global Impression (CGI) scale | Baseline - Weeks 1 and 12 | Assessment by the physician of the overall efficacy by CGI scale after 1- and 12-week treatment period. |
| Secondary | Frequency of treatment-related adverse events | 12 weeks | Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses, plasma Lithium concentration. |
Source ClinicalTrials.gov
Outcomes0
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/NCT03210480
GET https://conductscience.org/api/trials/v1/NCT03210480/registered