Adults 7 to 17, any sex, with Mood Disorder or Mental Disorder Diagnosed in Childhood. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).Primary· 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.
Group
Value
95% CI
Add-on Citalopram Following Optimized Methylphenidate
35
Add-on Placebo Following Optimized Methylphenidate
6
Irritability Severity at 8th Week of Trial.Secondary· 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).
Group
Value
95% CI
Add-on Citalopram Following Optimized Methylphenidate
3.1
± 0.3
Add-on Placebo Following Optimized Methylphenidate
3.9
± 0.3
Functional Impairment at 8th Week of TrialSecondary· 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.
Group
Value
95% CI
Add-on Citalopram Following Optimized Methylphenidate
52.6
± 2.3
Add-on Placebo Following Optimized Methylphenidate
47.2
± 2.1
Depressive Symptoms at 8th Week of TrialSecondary· 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.
Group
Value
95% CI
Add-on Citalopram Following Optimized Methylphenidate
28.6
± 1.8
Add-on Placebo Following Optimized Methylphenidate
30.1
± 1.8
Anxiety Symptoms at 8th Week of TrialSecondary· 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.
Group
Value
95% CI
Add-on Citalopram Following Optimized Methylphenidate
12.0
± 1.2
Add-on Placebo Following Optimized Methylphenidate
13.4
± 1.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event information was collected weekly during the study, including the 8th weeks of the trial..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Add-on Citalopram Following Optimized Methylphenidate
Serious: 0/23 (0%)
Deaths: 0/23
Add-on Placebo Following Optimized Methylphenidate
Severe mood dysregulation (SMD) is a very common syndrome in children. Its symptoms include very severe irritability, including persistent anger and frequent outbursts, as well as distractibility, hyperactivity, and other symptoms of attention deficit hyperactivity disorder (ADHD). Many children with SMD receive the diagnosis of bipolar disorder (BD) in the community, although they do not have clear manic episodes (with symptoms such as extreme happiness and decreased need for sleep). Because SMD has not been studied in depth, we do not know which medications are most helpful to those with SMD. This study will evaluate the effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as Ritalin ) when combined (or not combined) with the antidepressant citalopram (Celexa ) in treating symptoms of SMD in children and adolescents. This study will provide information about how to treat SMD in youth.
This study will include approximately 80 patients between 7 and 17 years of age with SMD. The patient s symptoms must have started before age 12.
The study will consist of four phases carried out over 4 to 5 months. During Phase 1, the patient will undergo blood and urine tests, and will gradually taper off his or her medication. The duration of this phase depends on the patient s medication before starting the study. In Phase 2, the patient remains off all medication for 1 week. In Phase 3, the patient will be treated with MPH for 2 weeks, and then will be randomly assigned to receive either MPH plus citalopram or MPH plus a placebo for a further 8 weeks. In Phase 4, the researchers will evaluate the effectiveness of the medications taken, and begin an open treatment phase using medications that they deem appropriate for that patient (this may include MPH with citalopram and/or other medication combinations).
Most patients will be admitted to the Pediatric Behavioral Health Unit at the National Institutes of Health Clinical Center during the medication withdrawal part of the study (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or in day treatment, depending on what is in his or her best interests.
...
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health (NIMH)
Last refreshed: 7 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00794040.