Trial · NCT02909504
Gao NARASD Lithium Study
NCT02909504, Phase 4, Terminated, Keming Gao; results first posted 2020-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gao NARASD Lithium Study. Trials, record NCT02909504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02909504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gao NARASD Lithium Study
- NCT number
- NCT02909504
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 24 participants, actual
- Lead sponsor
- Keming Gao
- Conditions
- Bipolar Disorder
- Interventions
- Lithium
- First posted
- 2016-09-21
- Last updated
- 2020-07-10
- Results first posted
- 2020-07-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Baseline and Week 16 | Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a \>=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a \>=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Baseline and Week 16 | While we planned to analyze \~45 molecules of interest, poor quality of antibodies to some proteins \& financial limitations limited us to only 28 proteins. The number of participants analyzed for protein expression differs from baseline characteristic and varies below as not all subjects had high enough levels of a particular protein to be analyzed. | fluorescence intensity | MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Non Responders | NLRP3 | 30.73 | Standard Deviation 5.66 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Responders | NLRP3 | 26.00 | Standard Deviation 7.25 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Non Responders | PDEB4 | 28.15 | Standard Deviation 9.12 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Responders | PDEB4 | 27.31 | Standard Deviation 5.78 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Non Responders | BAK | 11.16 | Standard Deviation 2.08 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Responders | BAK | 11.50 | Standard Deviation 2.88 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Non Responders | p-Fyn Yes | 12.49 | Standard Deviation 4.46 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Responders | p-Fyn Yes | 13.33 | Standard Deviation 6.44 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Non Responders | HMGB1 | 23.18 | Standard Deviation 8.69 | fluorescence intensity |
| Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Lithium Responders | HMGB1 | 22.61 | Standard Deviation 6.58 | fluorescence intensity |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium | 24 | |
| Overall Study | COMPLETED | Lithium | 12 | |
| Overall Study | NOT COMPLETED | Lithium | 12 |
Source ClinicalTrials.gov
Adverse events12
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 | Increased Thirst | General disorders | Lithium | 6 | 24 | |
| other | Dry Mouth | General disorders | Lithium | 2 | 24 | |
| other | Diarrhea | Gastrointestinal disorders | Lithium | 2 | 24 | |
| other | Cognitive Impairment | Psychiatric disorders | Lithium | 1 | 24 | |
| other | Stomach Upset | Gastrointestinal disorders | Lithium | 1 | 24 | |
| other | Increased Daytime Sleepiness | General disorders | Lithium | 1 | 24 | |
| other | Blurred Vision | Eye disorders | Lithium | 1 | 24 | |
| other | Dizziness | General disorders | Lithium | 1 | 24 | |
| other | Itching | Skin and subcutaneous tissue disorders | Lithium | 1 | 24 | |
| other | Decreased Sexual Interest | Reproductive system and breast disorders | Lithium | 1 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium | 0 | 24 |
| Total, other adverse events | Lithium | 20 | 24 |
| Total, serious adverse events | Lithium | 0 | 24 |
Source ClinicalTrials.gov
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/NCT02909504
GET https://conductscience.org/api/trials/v1/NCT02909504/results?page=2