Trial · NCT06591091
Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
NCT06591091, Phase 2, Recruiting, University of Illinois Chicago
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression. Trials, record NCT06591091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06591091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
- NCT number
- NCT06591091
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- University of Illinois Chicago
- Conditions
- Depression
- Interventions
- Clemastine Fumarate, Placebo
- First posted
- 2024-09-19
- Last updated
- 2026-06-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency, Intensity and Burden of Side Effects Rating Scale | 12 weeks | The investigator will examine the safety of clemastine using the Frequency, Intensity, and Burden of Side Effects Rating Scale (FIBSER). The FIBSER is scored from 0-6, with higher scores indicating worse outcomes |
| Primary | Montgomery-Asberg Rating Scale for Depression | 12 weeks | The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on clinical outcomes as indexed by the Montgomery-Asberg Rating Scale for Depression (MADRS). The MADRS is scored from 0-60, with higher scores indicating a worse outcome |
| Primary | Quantitative Anisotropy | 12 weeks | The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in quantitative anisotropy (QA). QA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity |
| Primary | Fractional Anisotropy | 12 weeks | The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in fractional anisotropy (FA). FA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity |
| Secondary | Trail Making Test Part A and Part B | 12 weeks | The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on cognitive outcomes as indexed by Trail Making Test Parts A and B. The Trail Making Test A and B is scored by the time to completion (seconds) and number of errors, with higher scores indicating worse performance. For TMT Part A and Part B, the "average" and "deficient" scores are categorized as follows: TMT Part A 29 seconds (average) Over 79 seconds (Deficient) TMT Part B 75 seconds (average) Over 273 seconds (Deficient) |
| Secondary | Orientation Dispersion Index | 12 weeks | The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in neurite orientation dispersion and density imaging (NODDI)-derived orientation dispersion index (ODI). The ODI has no units but ranges from 0-1, with higher values indicating more neurite dispersion. |
| Secondary | Neurite Density Index | 12 weeks | The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in neurite orientation dispersion and density imaging (NODDI)-derived measured neurite density index (NDI). The NDI has no units but ranges from 0-1, with higher values indicating more intracellular diffusion |
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
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/NCT06591091
GET https://conductscience.org/api/trials/v1/NCT06591091/registered