Trial Outcomes & Findings for Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression (NCT NCT01479829)

Results Overview

Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, response to treatment is defined as a reduction in the HDRS-17 score of at least 50% after 8 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-04-29

Participant Flow

Participants were recruited from an outpatient psychiatric clinic

One-hundred subjects consented to participate in this study. Among these individuals, 27 participants were screen failures and eight participants withdrew prior to randomization. The remaining 65 participants were randomized and took at least one study capsule

Participant milestones

Participant milestones
Measure	Intervention Cohort Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.	Control Cohort Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
Overall Study STARTED	35	30
Overall Study COMPLETED	27	20
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Cohort Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.	Control Cohort Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
Overall Study Withdrawal by Subject	8	10

Baseline Characteristics

Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Cohort n=27 Participants Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.	Control Cohort n=20 Participants Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.	Total n=47 Participants Total of all reporting groups
Age, Continuous	39.48 years STANDARD_DEVIATION 10.73 • n=93 Participants	46.15 years STANDARD_DEVIATION 13.50 • n=4 Participants	42.32 years STANDARD_DEVIATION 12.31 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	7 Participants n=4 Participants	19 Participants n=27 Participants
Race/Ethnicity, Customized Self-described race · White	19 Participants n=93 Participants	13 Participants n=4 Participants	32 Participants n=27 Participants
Race/Ethnicity, Customized Self-described race · non-White	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Region of Enrollment United States	27 participants n=93 Participants	20 participants n=4 Participants	47 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The analysis population is defined as all participants who completed at least eight weeks of treatment

Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, response to treatment is defined as a reduction in the HDRS-17 score of at least 50% after 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	Intervention Cohort n=27 Participants Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.	Control Cohort n=20 Participants Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
Response to Treatment Response	21 Participants	9 Participants
Response to Treatment No Response	6 Participants	11 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The analysis population is defined as all participants who completed at least eight weeks of treatment

Participants complete the Hamilton Depression Rating Scale (HDRS-17). The HDRS-17 is a clinician-administered assessment scale measuring the melancholic and physical symptoms of depression. Possible scores range from 0 to 54 (i.e., where higher scores indicate worse depression). In this study, diisease remission is defined as an HDRS-17 score less than 8 points after 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	Intervention Cohort n=27 Participants Participants assigned to the intervention cohort receive 10mg escitalopram twice daily plus 200mg celecoxib twice daily.	Control Cohort n=20 Participants Participants assigned to the control cohort receive 10mg escitalopram twice daily plus placebo administered twice daily.
Disease Remission Remission	17 Participants	2 Participants
Disease Remission No Remission	10 Participants	18 Participants

Adverse Events

Intervention Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Angelos Halaris

Loyola University Medical Center

Phone: 708-216-3272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place