Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

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ClinicalTrials.gov Identifier: NCT00562861

Recruitment Status : Completed

First Posted : November 22, 2007

Results First Posted : February 13, 2017

Last Update Posted : March 24, 2017

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Tufts Medical Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Conditions	Bipolar Disorder Bipolar Depression
Interventions	Drug: citalopram + mood stabilizer Drug: placebo + mood stabilizer
Enrollment	119

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Mood Stabilizer Plus Citalopram	Mood Stabilizer Plus Placebo
Arm/Group Description	citalopram + mood stabilizer: Cital...	Mood stabilizer alone will be the t...
Arm/Group Description	citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.	Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
Period Title: Overall Study
Started	60	59
Completed	40	48
Not Completed	20	11
Reason Not Completed
Adverse Event	1	1
Lack of Efficacy	5	5
noncompliance, moved	7	2
Lost to Follow-up	7	3

Baseline Characteristics

Arm/Group Title		Mood Stabilizer Plus Citalopram	Mood Stabilizer Plus Placebo	Total
Arm/Group Description		citalopram + mood stabilizer: Subje...	Placebo plus mood stabilizer: subje...	Total of all reporting groups
Arm/Group Description		citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.	Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers	Total of all reporting groups
Overall Number of Baseline Participants		60	59	119
Baseline Analysis Population Description		...
Baseline Analysis Population Description		These subjects met inclusion/exclusion criteria and were randomized to citalopram versus placebo.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	60 participants	59 participants	119 participants
		40.9 (12.6)	42.1 (11.3)	41.5 (11.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants	59 participants	119 participants
	Female	43 71.7%	31 52.5%	74 62.2%
	Male	17 28.3%	28 47.5%	45 37.8%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants	59 participants	119 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 1.7%	0 0.0%	1 0.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	21 35.0%	20 33.9%	41 34.5%
	White	36 60.0%	35 59.3%	71 59.7%
	More than one race	2 3.3%	4 6.8%	6 5.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	60 participants	59 participants	119 participants
United States		60	59	119

Outcome Measures

1.Primary Outcome


Title	MADRS Rating Scale Change
Description	Montgomery Asberg Depression Rating scale assessed in mixed effects re...
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

All patients randomized were analyzed in intent to treat manner.


Arm/Group Title	Citalopram	Placebo
Arm/Group Description:	Mood stabilizers given as part of s...	Mood stabilizers given as part of s...
Arm/Group Description:	Mood stabilizers given as part of standard treatment plus double-blind citalopram	Mood stabilizers given as part of standard treatment plus double-blind placebo
Overall Number of Participants Analyzed	60	59
Mean (Standard Deviation) Unit of Measure: units on a scale
	13.1 (8.4)	15.2 (9.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Citalopram, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.17
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	F value
	Estimated Value	1.88
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events are reported for 1 year of follow-up during the randomized trial.
Adverse Event Reporting Description	All patients were systematically interviewed for the adverse events reported.

Arm/Group Title	Citalopram		Placebo
Arm/Group Description	Mood stabilizers given as part of s...		Mood stabilizers given as part of s...
Arm/Group Description	Mood stabilizers given as part of standard treatment plus double-blind citalopram		Mood stabilizers given as part of standard treatment plus double-blind placebo
All-Cause Mortality
	Citalopram		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Citalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/60 (1.67%)		0/59 (0.00%)
Psychiatric disorders
suicide ^* [1]	1/60 (1.67%)	1	0/59 (0.00%)	0
* Indicates events were collected by non-systematic assessment [1] Subject committed suicide which was judged to be unrelated to administration of citalopram after review by investigators and evaluation by institutional review board.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Citalopram		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/60 (38.33%)		15/59 (25.42%)
Gastrointestinal disorders
nausea ^†	3/60 (5.00%)	3	6/59 (10.17%)	6
diarrhea ^†	1/60 (1.67%)	1	5/59 (8.47%)	5
Nervous system disorders
dry mouth ^†	6/60 (10.00%)	6	0/59 (0.00%)	0
sexual dysfunction ^†	5/60 (8.33%)	5	0/59 (0.00%)	0
headache ^†	4/60 (6.67%)	4	6/59 (10.17%)	6
tremor ^†	0/60 (0.00%)	0	4/59 (6.78%)	4
Psychiatric disorders
sedation ^†	8/60 (13.33%)	8	3/59 (5.08%)	3
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Nassir Ghaemi
Organization:	Tufts Medical Center
Phone:	6176365735
EMail:	nghaemi@tuftsmedicalcenter.org

Layout table for additonal information

Responsible Party:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT00562861 History of Changes
Other Study ID Numbers:	MH78060-01A1 5R01MH078060-04 ( U.S. NIH Grant/Contract )
First Submitted:	November 20, 2007
First Posted:	November 22, 2007
Results First Submitted:	July 7, 2016
Results First Posted:	February 13, 2017
Last Update Posted:	March 24, 2017

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