Trial · NCT01714310

Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation

NCT01714310, Phase 2, Completed, University of California, Los Angeles; results first posted 2018-02-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation. Trials, record NCT01714310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01714310

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation
NCT number: NCT01714310
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: University of California, Los Angeles
Conditions: Severe Mood Dysregulation
Interventions: lisdexamfetamine, Placebo, fluoxetine
First posted: 2012-10-25
Last updated: 2018-02-26
Results first posted: 2018-02-26
Limitations and caveats: Study was designed as an initial feasibility and proof of concept trial. Initial power analysis suggested need to randomize N=50 participants. Recruitment was much more difficult than expected, leading to small sample size.

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Global Impression-Severity-Severe Mood Dysregulation	Baseline through week 12.	A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.
Secondary	ADHD-IV Rating Scale	Baseline through week 12.	A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
Secondary	Conners Parent Global Index	Baseline through week 3.	Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.
Secondary	Conners Global Index Emotional Lability Subscale - Parent Report	Baseline to week 3.	A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.
Secondary	Conners Global Index Restless-Impulsive Subscale Parent Report	Baseline through week 3.	A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.
Secondary	Conners Teacher Global Index	Baseline through week 3.	Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.
Secondary	Affective Reactivity Index - Parent Report	Baseline through week 12.	A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Secondary	Revised Modified Overt Aggression Scale - Total Score	Baseline through week 12.	A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.
Secondary	Clinical Global Impression - Improvement	Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.	Percentage improved by treatment group
Secondary	Height	Baseline through week 12.	A dimensional measure assessed in cms.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Global Impression-Severity-Severe Mood Dysregulation	Baseline through week 12.	Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	ADHD-IV Rating Scale	Baseline through week 12.	Participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Conners Parent Global Index	Baseline through week 3.	Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Conners Global Index Emotional Lability Subscale - Parent Report	Baseline to week 3.	Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Conners Global Index Restless-Impulsive Subscale Parent Report	Baseline through week 3.	Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Conners Teacher Global Index	Baseline through week 3.	Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Affective Reactivity Index - Parent Report	Baseline through week 12.	Some participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Revised Modified Overt Aggression Scale - Total Score	Baseline through week 12.	Some participants discontinued as trial progressed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression - Improvement	Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.	Some participants discontinued as trial progressed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Height	Baseline through week 12.	Participants discontinued as trial progressed.	cm.	LEAST_SQUARES_MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group216

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Clinical Global Impression-Severity-Severe Mood Dysregulation	Fluoxetine	Baseline	4.91	Standard Error .53	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Placebo	Baseline	3.62	Standard Error .48	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Open Lisdexamfetamine	Baseline	4.30	Standard Error .32	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Fluoxetine	Week 4	4.42	Standard Error .34	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Placebo	Week 4	4.57	Standard Error .31	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Open Lisdexamfetamine	Week 4	4.31	Standard Error .19	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Fluoxetine	Week 5	4.15	Standard Error .36	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Placebo	Week 5	3.51	Standard Error .32	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Fluoxetine	Week 6	3.67	Standard Error .34	units on a scale
Clinical Global Impression-Severity-Severe Mood Dysregulation	Placebo	Week 6	3.90	Standard Error .33	units on a scale

1 to 10 of 216Source ClinicalTrials.gov

See all 216 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open Lisdexamfetamine Titration	STARTED	Fluoxetine	0
Open Lisdexamfetamine Titration	STARTED	Placebo	0
Open Lisdexamfetamine Titration	STARTED	Open Lisdexamfetamine	34
Open Lisdexamfetamine Titration	COMPLETED	Fluoxetine	0
Open Lisdexamfetamine Titration	COMPLETED	Placebo	0
Open Lisdexamfetamine Titration	COMPLETED	Open Lisdexamfetamine	30
Open Lisdexamfetamine Titration	NOT COMPLETED	Fluoxetine	0
Open Lisdexamfetamine Titration	NOT COMPLETED	Placebo	0
Open Lisdexamfetamine Titration	NOT COMPLETED	Open Lisdexamfetamine	4
Double Blind Adjunctive Treatment	STARTED	Fluoxetine	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events78

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	Wish to be dead	Psychiatric disorders	Fluoxetine	1	12	3
other	Wish to be dead	Psychiatric disorders	Placebo	2	14	2
other	Wish to be dead	Psychiatric disorders	Open Lisdexamfetamine	0	34	0
other	Suicidal ideation without intent	Psychiatric disorders	Fluoxetine	1	12	1
other	Suicidal ideation without intent	Psychiatric disorders	Placebo	0	14	0
other	Suicidal ideation without intent	Psychiatric disorders	Open Lisdexamfetamine	0	34	0
other	Headache	Nervous system disorders	Fluoxetine	1	12	1
other	Headache	Nervous system disorders	Placebo	1	14	1
other	Headache	Nervous system disorders	Open Lisdexamfetamine	5	34	8
other	Feeling drowsy/sleep	General disorders	Fluoxetine	1	12	2

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fluoxetine	0	12
Total, all-cause mortality	Placebo	0	14
Total, all-cause mortality	Open Lisdexamfetamine	0	34
Total, other adverse events	Fluoxetine	8	12
Total, other adverse events	Placebo	10	14
Total, other adverse events	Open Lisdexamfetamine	30	34
Total, serious adverse events	Fluoxetine	0	12
Total, serious adverse events	Placebo	0	14
Total, serious adverse events	Open Lisdexamfetamine	0	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
U01MH093582	Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation	MCGOUGH, JAMES JOHN	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE OF MENTAL HEALTH	2012 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01714310

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API reference For AI assistants