Trial · NCT00794040
A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation
NCT00794040, Phase 2, Completed, National Institute of Mental Health (NIMH); results first posted 2019-05-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation. Trials, record NCT00794040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00794040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation
- NCT number
- NCT00794040
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Mood Disorder, Mental Disorder Diagnosed in Childhood, Attention Deficit and Disruptive Behavior Disorder, Attention Deficit Hyperactivity Disorder
- Interventions
- Add-on citalopram following optimized methylphenidate, Add-on placebo following optimized methylphenidate
- First posted
- 2008-11-19
- Last updated
- 2019-05-07
- Results first posted
- 2019-05-07
- Limitations and caveats
The sample size was smaller than initially planned. Our primary measure of irritability Aberrant Behavior Checklist - Irritability subscale, did not prove suitable for the current study due to its design (i.e., different environments and informants)
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants That "Much Improved" (Score of 2) in, or "Completely Recovered" (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I). | Collected weekly during the 8-week trial. The 8th-week outcome is reported. | A measure of change of irritability severity taking the baseline before randomization as a reference. Scores range 1 to 8, in which 1=Completely recovered,... 5=Unchanged,... 8=Much worse. Percentage of participants who responded are based on an estimation and might not match exactly with discrete numbers of participants based on the denominator. |
| Secondary | Irritability Severity at 8th Week of Trial. | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Clinical Global Impression-Severity (CGI-S): A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients). |
| Secondary | Functional Impairment at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Difference in functional impairment at 8th week of trial as measured with Children's Global Impression Scale (CGAS) with scores ranging from 1=Most impaired to 100=Not impaired at all. |
| Secondary | Depressive Symptoms at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Difference in depressive symptoms at 8th week of trial as measured with Children's Depression Rating Scale (CDRS) with scores ranging 17-113, where scores \>40 are considered over the clinical threshold, and scores \<28 are considered within the healthy range. |
| Secondary | Anxiety Symptoms at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Difference in anxiety symptoms at 8th week of trial as measured with the Pediatric Anxiety Rating Scale (PARS) with scores ranging 0-25. Higher values represent a worse outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I). | Collected weekly during the 8-week trial. The 8th-week outcome is reported. | Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants | estimated percentage of participants | NUMBER |
| SECONDARY | Irritability Severity at 8th Week of Trial. | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants. | units on a scale | MEAN |
| SECONDARY | Functional Impairment at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants. | units on a scale | MEAN |
| SECONDARY | Depressive Symptoms at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants. | units on a scale | MEAN |
| SECONDARY | Anxiety Symptoms at 8th Week of Trial | Collected weekly during the 8th week trial. The 8th-week outcome is reported. | Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I). | Add-on Citalopram Following Optimized Methylphenidate | 35 | estimated percentage of participants | ||
Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I). | Add-on Placebo Following Optimized Methylphenidate | 6 | estimated percentage of participants | ||
| Irritability Severity at 8th Week of Trial. | Add-on Citalopram Following Optimized Methylphenidate | 3.1 | Standard Error 0.3 | units on a scale | |
| Irritability Severity at 8th Week of Trial. | Add-on Placebo Following Optimized Methylphenidate | 3.9 | Standard Error 0.3 | units on a scale | |
| Functional Impairment at 8th Week of Trial | Add-on Citalopram Following Optimized Methylphenidate | 52.6 | Standard Error 2.3 | units on a scale | |
| Functional Impairment at 8th Week of Trial | Add-on Placebo Following Optimized Methylphenidate | 47.2 | Standard Error 2.1 | units on a scale | |
| Depressive Symptoms at 8th Week of Trial | Add-on Citalopram Following Optimized Methylphenidate | 28.6 | Standard Error 1.8 | units on a scale | |
| Depressive Symptoms at 8th Week of Trial | Add-on Placebo Following Optimized Methylphenidate | 30.1 | Standard Error 1.8 | units on a scale | |
| Anxiety Symptoms at 8th Week of Trial | Add-on Citalopram Following Optimized Methylphenidate | 12.0 | Standard Error 1.2 | units on a scale | |
| Anxiety Symptoms at 8th Week of Trial | Add-on Placebo Following Optimized Methylphenidate | 13.4 | Standard Error 1.2 | 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 | Add-on Citalopram Following Optimized Methylphenidate | 25 | |
| Overall Study | STARTED | Add-on Placebo Following Optimized Methylphenidate | 28 | |
| Overall Study | COMPLETED | Add-on Citalopram Following Optimized Methylphenidate | 22 | |
| Overall Study | COMPLETED | Add-on Placebo Following Optimized Methylphenidate | 23 | |
| Overall Study | NOT COMPLETED | Add-on Citalopram Following Optimized Methylphenidate | 3 | |
| Overall Study | NOT COMPLETED | Add-on Placebo Following Optimized Methylphenidate | 5 |
Source ClinicalTrials.gov
Adverse events94
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 | Dry mouth | Gastrointestinal disorders | Add-on Citalopram Following Optimized Methylphenidate | 3 | 23 | |
| other | Dry mouth | Gastrointestinal disorders | Add-on Placebo Following Optimized Methylphenidate | 4 | 26 | |
| other | Drooling | Gastrointestinal disorders | Add-on Citalopram Following Optimized Methylphenidate | 2 | 23 | |
| other | Drooling | Gastrointestinal disorders | Add-on Placebo Following Optimized Methylphenidate | 0 | 26 | |
| other | Increased thirst | Gastrointestinal disorders | Add-on Citalopram Following Optimized Methylphenidate | 3 | 23 | |
| other | Increased thirst | Gastrointestinal disorders | Add-on Placebo Following Optimized Methylphenidate | 3 | 26 | |
| other | Trouble swallowing | Gastrointestinal disorders | Add-on Citalopram Following Optimized Methylphenidate | 2 | 23 | |
| other | Trouble swallowing | Gastrointestinal disorders | Add-on Placebo Following Optimized Methylphenidate | 3 | 26 | |
| other | Nausea | Gastrointestinal disorders | Add-on Citalopram Following Optimized Methylphenidate | 10 | 23 | |
| other | Nausea | Gastrointestinal disorders | Add-on Placebo Following Optimized Methylphenidate | 8 | 26 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Add-on Citalopram Following Optimized Methylphenidate | 0 | 23 |
| Total, all-cause mortality | Add-on Placebo Following Optimized Methylphenidate | 0 | 26 |
| Total, other adverse events | Add-on Citalopram Following Optimized Methylphenidate | 23 | 23 |
| Total, other adverse events | Add-on Placebo Following Optimized Methylphenidate | 24 | 26 |
| Total, serious adverse events | Add-on Citalopram Following Optimized Methylphenidate | 0 | 23 |
| Total, serious adverse events | Add-on Placebo Following Optimized Methylphenidate | 0 | 26 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Add-on Citalopram Following Optimized Methylphenidate vs Add-on Placebo Following Optimized Methylphenidate: deaths from any cause | Trial comparisons |
| Add-on Citalopram Following Optimized Methylphenidate vs Add-on Placebo Following Optimized Methylphenidate: 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/NCT00794040
GET https://conductscience.org/api/trials/v1/NCT00794040/events?page=2