Trial Outcomes & Findings for [11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine (NCT NCT05522673)

Last Updated: 2024-03-05

Results Overview

Participants received 11C-R-Rolipram during PET scan and were scanned for 90 minutes with arterial blood sampling. Volume of distribution was calculated using two-tissue compartmental modeling. Participants had one PET scan pre-Ketamine and a second PET scan post-Ketamine administration.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

90 minutes after injection of 11C-R-Rolipram

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Major Depression Disorder (MDD) Participants with major depressive disorder received 20 mCi of \[11C\](R)-rolipram intravenously for two positron emission tomography (PET) scans, prior to and after ketamine infusion as well as brain MRI
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Major Depression Disorder (MDD) n=1 Participants Participants with major depressive disorder received 20 mCi of \[11C\](R)-rolipram intravenously for two positron emission tomography (PET) scans, prior to and after ketamine infusion as well as brain MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 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	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes after injection of 11C-R-Rolipram

Population: Analysis included participant who completed the study

Outcome measures

Outcome measures
Measure	Subjects With Major Depression Disorder (MDD) n=1 Participants Participants with major depressive disorder received 20 mCi of \[11C\](R)-rolipram intravenously for two positron emission tomography (PET) scans, prior to and after ketamine infusion as well as brain MRI
Whole Brain Total Distribution Volume (VT) Pre-Ketamine	0.512639 mL x cm^3
Whole Brain Total Distribution Volume (VT) Post-Ketamine	0.443411 mL x cm^3

SECONDARY outcome

Timeframe: Within two weeks of start of study (Pre) and within 7 days of Ketamine infusion (Post)

Population: Analysis included participant who completed the study

Participants rated level of depression using Montgomery-Åsberg Depression Rating Scale (MADRS). MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 with overall score ranging from 0 to 60. Higher MADRS score indicates more severe depression. Scores were measured at two visits, pre-Ketamine administration and a second visit post-Ketamine administration.

Outcome measures

Outcome measures
Measure	Subjects With Major Depression Disorder (MDD) n=1 Participants Participants with major depressive disorder received 20 mCi of \[11C\](R)-rolipram intravenously for two positron emission tomography (PET) scans, prior to and after ketamine infusion as well as brain MRI
Measure of Level of Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) Pre-Ketamine	28 score on a scale
Measure of Level of Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) Post-Ketamine	25 score on a scale

SECONDARY outcome

Timeframe: Within two weeks of start of study (Pre) and within 7 days of Ketamine infusion (Post)

Population: Analysis included participant who completed the study

Participants rated level of depression using the Hamilton Depression (HAM-D) Rating Scale. The HAM-D is a clinician-administered depression assessment scale which contains 17 items pertaining to symptoms of depression experienced over the past week. Eight items are rated 0-4 and nine items are rated 0-2 for a minimum score of zero and a maximum score of 50. Higher value indicates worsening depression. Scores were measured at two visits, prior to PET scan pre-Ketamine and a second visit post-Ketamine administration.

Outcome measures

Outcome measures
Measure	Subjects With Major Depression Disorder (MDD) n=1 Participants Participants with major depressive disorder received 20 mCi of \[11C\](R)-rolipram intravenously for two positron emission tomography (PET) scans, prior to and after ketamine infusion as well as brain MRI
Measure of Level of Depression Using the Hamilton Depression (HAM-D) Rating Scale Pre-Ketamine	17 score on a scale
Measure of Level of Depression Using the Hamilton Depression (HAM-D) Rating Scale Post-Ketamine	16 score on a scale

Adverse Events

Subjects With Major Depression Disorder (MDD)

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. Robert Innis

National Institute of Mental Health (NIMH)

Phone: 301-594-1368

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place