Trial Outcomes & Findings for Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram (NCT NCT00562861)

Last Updated: 2017-03-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

119 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Mood Stabilizer Plus Citalopram 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 Plus Placebo Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
Overall Study STARTED	60	59
Overall Study COMPLETED	40	48
Overall Study NOT COMPLETED	20	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Mood Stabilizer Plus Citalopram 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 Plus Placebo Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	5	5
Overall Study noncompliance, moved	7	2
Overall Study Lost to Follow-up	7	3

Baseline Characteristics

Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mood Stabilizer Plus Citalopram n=60 Participants citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.	Mood Stabilizer Plus Placebo n=59 Participants Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers	Total n=119 Participants Total of all reporting groups
Age, Continuous	40.9 years STANDARD_DEVIATION 12.6 • n=5 Participants	42.1 years STANDARD_DEVIATION 11.3 • n=7 Participants	41.5 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	31 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	28 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	59 participants n=7 Participants	119 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All patients randomized were analyzed in intent to treat manner.

Outcome measures

Outcome measures
Measure	Citalopram n=60 Participants Mood stabilizers given as part of standard treatment plus double-blind citalopram	Placebo n=59 Participants Mood stabilizers given as part of standard treatment plus double-blind placebo
MADRS Rating Scale Change	13.1 units on a scale Standard Deviation 8.4	15.2 units on a scale Standard Deviation 9.9

Adverse Events

Citalopram

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Citalopram n=60 participants at risk Mood stabilizers given as part of standard treatment plus double-blind citalopram	Placebo n=59 participants at risk Mood stabilizers given as part of standard treatment plus double-blind placebo
Psychiatric disorders suicide	1.7% 1/60 • Number of events 1 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	0.00% 0/59 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.

Other adverse events

Other adverse events
Measure	Citalopram n=60 participants at risk Mood stabilizers given as part of standard treatment plus double-blind citalopram	Placebo n=59 participants at risk Mood stabilizers given as part of standard treatment plus double-blind placebo
Psychiatric disorders sedation	13.3% 8/60 • Number of events 8 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	5.1% 3/59 • Number of events 3 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Nervous system disorders dry mouth	10.0% 6/60 • Number of events 6 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	0.00% 0/59 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Nervous system disorders sexual dysfunction	8.3% 5/60 • Number of events 5 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	0.00% 0/59 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Nervous system disorders headache	6.7% 4/60 • Number of events 4 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	10.2% 6/59 • Number of events 6 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Gastrointestinal disorders nausea	5.0% 3/60 • Number of events 3 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	10.2% 6/59 • Number of events 6 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Gastrointestinal disorders diarrhea	1.7% 1/60 • Number of events 1 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	8.5% 5/59 • Number of events 5 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.
Nervous system disorders tremor	0.00% 0/60 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.	6.8% 4/59 • Number of events 4 • Adverse events are reported for 1 year of follow-up during the randomized trial. All patients were systematically interviewed for the adverse events reported.

Additional Information

Nassir Ghaemi

Tufts Medical Center

Phone: 6176365735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place