Trial · NCT01811147

Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

NCT01811147, Phase 4, Completed, The Cleveland Clinic; results first posted 2019-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI. Trials, record NCT01811147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01811147

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Trial

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

Title: Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
NCT number: NCT01811147
Status: Completed
Phases: Phase 4
Enrollment: 192 participants, actual
Lead sponsor: The Cleveland Clinic
Conditions: Bipolar Disorder, Major Depression
Interventions: Selective Serotonin Reuptake Inhibitor (SSRI)
First posted: 2013-03-14
Last updated: 2019-12-02
Results first posted: 2019-12-02

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	HAM-D 17 Item: Hamilton Depression Rating Scale	24 months	Hamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).
Secondary	YMRS: Young Mania Rating Scale	24 months	Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (\>25)

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HAM-D 17 Item: Hamilton Depression Rating Scale	24 months		score on a scale	MEAN
SECONDARY	YMRS: Young Mania Rating Scale	24 months		score 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	Value	Spread	Units
HAM-D 17 Item: Hamilton Depression Rating Scale	High Risk Depression	6.6	Standard Deviation 6.62	score on a scale
HAM-D 17 Item: Hamilton Depression Rating Scale	Low Risk Depression	4.91	Standard Deviation 4.11	score on a scale
HAM-D 17 Item: Hamilton Depression Rating Scale	Healthy Control	2.333	Standard Deviation 2.732	score on a scale
HAM-D 17 Item: Hamilton Depression Rating Scale	Bipolar	3.75	Standard Deviation 4.992	score on a scale
YMRS: Young Mania Rating Scale	High Risk Depression	0.2	Standard Deviation 0.561	score on a scale
YMRS: Young Mania Rating Scale	Low Risk Depression	0	Standard Deviation 0	score on a scale
YMRS: Young Mania Rating Scale	Healthy Control	0	Standard Deviation 0	score on a scale
YMRS: Young Mania Rating Scale	Bipolar	1.75	Standard Deviation 3.5	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	High Risk Depression	51
Overall Study	STARTED	Low Risk Depression	56
Overall Study	STARTED	Healthy Control	49
Overall Study	STARTED	Bipolar	33
Overall Study	COMPLETED	High Risk Depression	15
Overall Study	COMPLETED	Low Risk Depression	11
Overall Study	COMPLETED	Healthy Control	6
Overall Study	COMPLETED	Bipolar	4
Overall Study	NOT COMPLETED	High Risk Depression	36
Overall Study	NOT COMPLETED	Low Risk Depression	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

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
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	High Risk Depression	2	51
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	Low Risk Depression	1	56
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	Healthy Control	0	49
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	Bipolar	0	33
other	Visit to Emergency Room	Social circumstances	High Risk Depression	1	51
other	Visit to Emergency Room	Social circumstances	Low Risk Depression	1	56
other	Visit to Emergency Room	Social circumstances	Healthy Control	0	49
other	Visit to Emergency Room	Social circumstances	Bipolar	0	33
other	Substance Abuse Treatment	Psychiatric disorders	High Risk Depression	0	51
other	Substance Abuse Treatment	Psychiatric disorders	Low Risk Depression	2	56

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High Risk Depression	0	51
Total, all-cause mortality	Low Risk Depression	0	56
Total, all-cause mortality	Healthy Control	0	49
Total, all-cause mortality	Bipolar	0	33
Total, other adverse events	High Risk Depression	3	51
Total, other adverse events	Low Risk Depression	4	56
Total, other adverse events	Healthy Control	0	49
Total, other adverse events	Bipolar	0	33
Total, serious adverse events	High Risk Depression	5	51
Total, serious adverse events	Low Risk Depression	3	56

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30579045	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 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/NCT01811147

GET https://conductscience.org/api/trials/v1/NCT01811147/events?page=2

API reference For AI assistants