Trial · NCT00233103
Treatment of Post-Traumatic Brain Injury (TBI) Depression
NCT00233103, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2015-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Post-Traumatic Brain Injury (TBI) Depression. Trials, record NCT00233103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00233103
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Post-Traumatic Brain Injury (TBI) Depression
- NCT number
- NCT00233103
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Depression
- Interventions
- Sertraline, Placebo
- First posted
- 2005-10-05
- Last updated
- 2015-11-13
- Results first posted
- 2015-11-13
- Limitations and caveats
- Sample size was small - those who dropped out could have reduced the differential effect.~Sample was heterogeneous for severity and time since injury.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Depression at Baseline | baseline | The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression. Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline. |
| Primary | Depression at End of Treatment | end of treatment, average of 10 weeks | Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention. The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression. |
| Secondary | BAI | Immediately post-intervention | The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression |
| Secondary | Life-3 | Immediately post-intervention at 10 weeks | Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Depression at Baseline | baseline | units on a scale | MEAN | |
| SECONDARY | BAI | Immediately post-intervention | units on a scale | MEAN | |
| SECONDARY | Life-3 | Immediately post-intervention at 10 weeks | units on a scale | MEAN | |
| PRIMARY | Depression at End of Treatment | end of treatment, average of 10 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Depression at Baseline | Sertraline | 27.5 | Standard Deviation 7.1 | units on a scale | |
| Depression at Baseline | Placebo | 25.2 | Standard Deviation 8.0 | units on a scale | |
| BAI | Sertraline | 11.1 | Standard Deviation 11.9 | units on a scale | |
| BAI | Placebo | 13.1 | Standard Deviation 11.6 | units on a scale | |
| Life-3 | Sertraline | 6.3 | Standard Deviation 8.0 | units on a scale | |
| Life-3 | Placebo | 4.9 | Standard Deviation 3.5 | units on a scale | |
| Depression at End of Treatment | Sertraline | 13.7 | Standard Deviation 9.7 | units on a scale | |
| Depression at End of Treatment | Placebo | 16.2 | Standard Deviation 9.6 | 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 | Sertraline | 27 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Sertraline | 22 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Sertraline | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events6
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 | anxiety | Psychiatric disorders | Sertraline | 1 | 22 | 1 |
| other | anxiety | Psychiatric disorders | Placebo | 0 | 19 | 0 |
| other | depression | Psychiatric disorders | Sertraline | 0 | 22 | 0 |
| other | depression | Psychiatric disorders | Placebo | 1 | 19 | 1 |
| other | allergic reaction | Skin and subcutaneous tissue disorders | Sertraline | 0 | 22 | 0 |
| other | allergic reaction | Skin and subcutaneous tissue disorders | Placebo | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sertraline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sertraline | 1 | 22 |
| Total, other adverse events | Placebo | 2 | 19 |
| Total, serious adverse events | Sertraline | 0 | 22 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19406291 | 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 |
|---|
| Sertraline vs Placebo: 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/NCT00233103
GET https://conductscience.org/api/trials/v1/NCT00233103/registered