Trial · NCT01689909
Reducing Suicidal Ideation Through Insomnia Treatment
NCT01689909, Phase 4, Completed, Augusta University; results first posted 2018-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reducing Suicidal Ideation Through Insomnia Treatment. Trials, record NCT01689909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01689909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing Suicidal Ideation Through Insomnia Treatment
- NCT number
- NCT01689909
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 103 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Insomnia, Depression, Suicidal Ideation
- Interventions
- Zolpidem-CR, Placebo
- First posted
- 2012-09-21
- Last updated
- 2022-02-16
- Results first posted
- 2018-06-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Scale for Suicide Ideation Index (SSI) | Over 8 weeks of treatment | This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation |
| Primary | Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale | 8 weeks of treatment | The suicide ideation scale of the C-SSRS is rated 0-5, with "0" meaning no suicidal ideation, "1" meaning a wish t be dead, "2" meaning non-specific active suicidal thoughts, "3" meaning active suicidal ideation with any methods but no plan or intent, "4" meaning active suicidal ideation with some intent but no specific plan, and "5" meaning active suicidal ideation with intent and a specific plan |
| Secondary | Dysfunctional Beliefs and Attitudes About Sleep | 8 weeks of treatment | The Dysfunctional Beliefs and Attitudes About Sleep scale has 16 items and is self administered. Each item is scored 0-10. The total score is an average of the scores of the 16 items. Hence the range of the total score is also 0-10, with higher scores indicating greater dysfunctional beliefs about sleep |
| Secondary | Disturbing Dreams and Nightmares Severity Index (DDNSI) | 8 weeks of treatment | This self-rated scale has 5 items, with asymmetric weighting of each item. The range of the total score is 0-37, with higher scores indicating worse nightmares |
| Secondary | Beck Hopelessness Scale (BHS) | 8 weeks of treatment | The Beck Hopelessness Scale is self administered and has 20 'true/false' choices. Some items are reversed scored. The range of scores for the total is 0-20, with higher scores indicating greater hopelessness |
| Secondary | Hamilton Rating Scale for Depression (HAM-D) | 8 weeks of treatment | This version of the Hamilton Rating Scale for Depression uses 24 items, with a possible total score ranging from 0-74, with higher scores indicating worse depression |
| Secondary | Insomnia Severity Index (ISI) | 8 weeks of treatment | The Insomnia Severity Index is self rated. It has 7 items, each scored 0-4. Therefore the range of scores is 0-28, with higher scores indicating worse insomnia |
| Other | Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale | 8 weeks of treatment | This is one of the subscales of the Basis 32. It is self-administered. This subscale has 7 items, each scored 0-4. The totals score is an average of the scores of these 7 items. Higher scores indicate more difficulty with daily living and role functioning. |
| Other | Actigraphy | 8 weeks of treatment | This device measures arm motion over time, reported as "average actigraphic activity Level". The scale is reported as a continuous measure ranging from 0-200, and reported as the average score for each hour for all 24-hours of the day. Higher score represent greater c=activity at that point in time |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Scale for Suicide Ideation Index (SSI) | Over 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| PRIMARY | Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale | 8 weeks of treatment | all evaluable randomized participants | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Dysfunctional Beliefs and Attitudes About Sleep | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Disturbing Dreams and Nightmares Severity Index (DDNSI) | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Beck Hopelessness Scale (BHS) | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Hamilton Rating Scale for Depression (HAM-D) | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Insomnia Severity Index (ISI) | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale | 8 weeks of treatment | units on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Actigraphy | 8 weeks of treatment | participants with depression, insomnia, and suicidality | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Scale for Suicide Ideation Index (SSI) | Zolpidem-CR | 4.66 | Standard Error 0.58 | units on a scale | |
| Scale for Suicide Ideation Index (SSI) | Placebo | 5.25 | Standard Error 0.59 | units on a scale | |
| Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale | Zolpidem-CR | 0.5447 | Standard Error 0.0869 | units on a scale | |
| Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale | Placebo | 0.8067 | Standard Error 0.0875 | units on a scale | |
| Dysfunctional Beliefs and Attitudes About Sleep | Zolpidem-CR | 6.03 | Standard Error 0.171 | units on a scale | |
| Dysfunctional Beliefs and Attitudes About Sleep | Placebo | 6.07 | Standard Error 0.171 | units on a scale | |
| Disturbing Dreams and Nightmares Severity Index (DDNSI) | Zolpidem-CR | 5.74 | Standard Error 0.710 | units on a scale | |
| Disturbing Dreams and Nightmares Severity Index (DDNSI) | Placebo | 6.44 | Standard Error 0.718 | units on a scale | |
| Beck Hopelessness Scale (BHS) | Zolpidem-CR | 9.40 | Standard Error 0.58 | units on a scale | |
| Beck Hopelessness Scale (BHS) | Placebo | 9.63 | Standard Error 0.58 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zolpidem-CR | 51 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | Zolpidem-CR | 51 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | Zolpidem-CR | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | cold symptoms and flu | Respiratory, thoracic and mediastinal disorders | Zolpidem-CR | 12 | 51 | 21 |
| other | cold symptoms and flu | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 52 | 9 |
| other | nausea and diarrhea | Gastrointestinal disorders | Zolpidem-CR | 9 | 51 | 14 |
| other | nausea and diarrhea | Gastrointestinal disorders | Placebo | 9 | 52 | 14 |
| other | headache | Nervous system disorders | Zolpidem-CR | 6 | 51 | 9 |
| other | headache | Nervous system disorders | Placebo | 6 | 52 | 11 |
| other | Other | General disorders | Zolpidem-CR | 4 | 51 | 14 |
| other | Other | General disorders | Placebo | 13 | 52 | 28 |
| serious | pregnancy then miscarriage | Pregnancy, puerperium and perinatal conditions | Zolpidem-CR | 1 | 51 | |
| serious | pregnancy then miscarriage | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 52 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zolpidem-CR | 0 | 51 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, other adverse events | Zolpidem-CR | 31 | 51 |
| Total, other adverse events | Placebo | 37 | 52 |
| Total, serious adverse events | Zolpidem-CR | 1 | 51 |
| Total, serious adverse events | Placebo | 0 | 52 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH095776 | 1/3-Reducing Suicial Ideation Through Insomnia Treatment (REST-IT) | MCCALL, WILLIAM VAUGHN | AUGUSTA UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zolpidem-CR vs Placebo: deaths from any cause | Trial comparisons |
| Zolpidem-CR vs Placebo: serious adverse events | 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/NCT01689909
GET https://conductscience.org/api/trials/v1/NCT01689909/registered