Trial Outcomes & Findings for Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging (NCT NCT02473250)

NCT ID: NCT02473250

Last Updated: 2024-12-31

Results Overview

Depression severity. Minimum=0, Maximum=60. Higher numbers correspond to greater depression severity. The percent change between week 0 and the last observation was calculated.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-12-31

Participant Flow

Participant milestones

Measure	Bipolar Depressed Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
Overall Study STARTED	40
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Bipolar Depressed Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
Overall Study Lost to Follow-up	10
Overall Study Physician Decision	5
Overall Study Did not tolerate medication washout	3
Overall Study Antidepressant effect of divalproex	2

Baseline Characteristics

Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging

Baseline characteristics by cohort

Measure	Bipolar Depressed n=40 Participants Bipolar depressed subjects had neuroimaging and treatment with a selective serotonin reuptake inhibitor in combination with a mood stabilizer. Fluoxetine was offered first, but citalopram was offered as an alternative if fluoxetine was not clinically appropriate.
Age, Continuous	37.0 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Depression severity. Minimum=0, Maximum=60. Higher numbers correspond to greater depression severity. The percent change between week 0 and the last observation was calculated.

Outcome measures

Measure

Bipolar Depressed n=20 Participants Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Montgomery-Asberg Depression Rating Scale

-39.24 Percent change in MADRS from baseline Standard Deviation 10.38

SECONDARY outcome

Timeframe: 6 weeks

Anxiety severity. Minimum=0, Maximum=56. The larger the value on the scale, the more intense the anxiety. The percent difference between week 0 and the last observation was calculated.

Outcome measures

Measure

Bipolar Depressed n=20 Participants Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Hamilton Anxiety Rating Scale

-13.95 Percent change in HAMA score Standard Deviation 70.38

SECONDARY outcome

Timeframe: 6 weeks

Measure of manic symptoms. Minimum=0, Maximum=60. The higher the value on the scale, the more intense the manic symptoms. The maximum value of YMRS over the six week clinical trial is reported.

Outcome measures

Measure

Bipolar Depressed n=20 Participants Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Young Mania Rating Scale

-5.75 Scores on a scale Standard Deviation 2.49

SECONDARY outcome

Timeframe: 6 weeks

General impression of symptoms by clinician. Minimum=1, Maximum=7. The higher value on the scale, the more symptomatic the patient is. The percent difference between week 0 and the last observation was calculated.

Outcome measures

Measure

Bipolar Depressed n=20 Participants Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Clinical Global Impression-1

-27.17 Percent change in CGI score Standard Deviation 25.06

Adverse Events

Bipolar Depressed

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Bipolar Depressed n=40 participants at risk Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate) Fluoxetine: Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate). Citalopram: Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Psychiatric disorders Psychiatric Hospitalization

5.0% 2/40 • Number of events 2 • Adverse event data were collected over the time that the participants were enrolled in the study. This time range varied depending on the research procedures performed. If all research procedures were performed, the participants were enrolled for 11 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Martin Lan MD PhD

Columbia University Irving Medical Center

Phone: 646 774 7610

Email: martin.lan@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place