Trial · NCT00562861

Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

NCT00562861, Phase 2, Phase 3, Completed, Tufts Medical Center; results first posted 2017-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram. Trials, record NCT00562861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00562861

On this page

Trial

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

Title: Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
NCT number: NCT00562861
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 119 participants, actual
Lead sponsor: Tufts Medical Center
Conditions: Bipolar Disorder, Bipolar Depression
Interventions: citalopram + mood stabilizer, placebo + mood stabilizer
First posted: 2007-11-22
Last updated: 2017-03-24
Results first posted: 2017-02-13

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	MADRS Rating Scale Change	6 weeks	Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	MADRS Rating Scale Change	6 weeks	All patients randomized were analyzed in intent to treat manner.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
MADRS Rating Scale Change	Citalopram		13.1	Standard Deviation 8.4	units on a scale
MADRS Rating Scale Change	Placebo		15.2	Standard Deviation 9.9	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Mood Stabilizer Plus Citalopram	60
Overall Study	STARTED	Mood Stabilizer Plus Placebo	59
Overall Study	COMPLETED	Mood Stabilizer Plus Citalopram	40
Overall Study	COMPLETED	Mood Stabilizer Plus Placebo	48
Overall Study	NOT COMPLETED	Mood Stabilizer Plus Citalopram	20
Overall Study	NOT COMPLETED	Mood Stabilizer Plus Placebo	11

Source ClinicalTrials.gov

Adverse events16

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	sedation	Psychiatric disorders	Citalopram	8	60	8
other	sedation	Psychiatric disorders	Placebo	3	59	3
other	dry mouth	Nervous system disorders	Citalopram	6	60	6
other	dry mouth	Nervous system disorders	Placebo	0	59	0
other	sexual dysfunction	Nervous system disorders	Citalopram	5	60	5
other	sexual dysfunction	Nervous system disorders	Placebo	0	59	0
other	headache	Nervous system disorders	Citalopram	4	60	4
other	headache	Nervous system disorders	Placebo	6	59	6
other	nausea	Gastrointestinal disorders	Citalopram	3	60	3
other	nausea	Gastrointestinal disorders	Placebo	6	59	6

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Citalopram
Total, all-cause mortality	Placebo
Total, other adverse events	Citalopram	23	60
Total, other adverse events	Placebo	15	59
Total, serious adverse events	Citalopram	1	60
Total, serious adverse events	Placebo	0	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33434956	DERIVED

Source PubMed

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
R01MH078060	Treatment for Bipolar Depression: Acute & Prophylactic Efficacy with Citalopram	GHAEMI, NASSIR	TUFTS MEDICAL CENTER	NATIONAL INSTITUTE OF MENTAL HEALTH	2007 to 2011

Source NIH RePORTER

Trial comparisons1

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

Comparison
Citalopram vs Placebo: serious adverse events

Source 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.

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/NCT00562861

GET https://conductscience.org/api/trials/v1/NCT00562861/registered

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