Trial Outcomes & Findings for Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole (NCT NCT01066897)

NCT ID: NCT01066897

Last Updated: 2017-05-16

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: throughout the 8 weeks
• Results posted on: 2017-05-16

Participant Flow

Participant milestones

Measure	Pramipexole Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole	Healthy Controls Non depressed, non treatment comparison group
Overall Study STARTED	7	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Pramipexole Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole	Healthy Controls Non depressed, non treatment comparison group
Overall Study Withdrawal by Subject	1	0
Overall Study stopped study after developing the flu.	1	0

Baseline Characteristics

Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole

Baseline characteristics by cohort

Measure	Pramipexole n=7 Participants Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole	Healthy Controls n=9 Participants Non depressed, non treatment comparison group from baseline	Total n=16 Participants Total of all reporting groups
Age, Continuous	44.00 years STANDARD_DEVIATION 14.12 • n=5 Participants	34.78 years STANDARD_DEVIATION 14.0 • n=7 Participants	38.81 years STANDARD_DEVIATION 14.41 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	6 Participants n=7 Participants	6 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	0 Participants n=5 Participants	1 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	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: throughout the 8 weeks

Population: \# of participants who dropped out due to medication side-effects

Outcome measures

Measure	Pramipexole n=7 Participants Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole	Healthy Controls Who Did Not Take Medication n=9 Participants
Number of Participants Who Discontinued Study Due to Side-effects of the Medication	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and weeks 8

Population: For two drop outs, used LOCF

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms.

Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained.

Outcome measures

Measure	Pramipexole n=7 Participants Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole	Healthy Controls Who Did Not Take Medication
% Change in Hamilton Depression Rating Scale From Baseline to week8	.46 percentage reduction in depression score Standard Deviation .42	—

PRIMARY outcome

Timeframe: baseline and Week 8

Population: Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.

Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Because of the small number of depressed patients and noisy/unusable data, analyses were not run.

Because of the small number of depressed patients and noisy/unusable data, analyses were not run.

Outcome measures

Outcome data not reported

Adverse Events

Pramipexole

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pramipexole n=7 participants at risk Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (\> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit. Pramipexole: Patients will received increasing dose of pramipexole
Nervous system disorders somnolence	14.3% 1/7 • Number of events 2 • From date of randomization, every two weeks, assessed up to 8 weeks. Adverse events were only collected for the pramipexole group.
Nervous system disorders nausea	14.3% 1/7 • Number of events 1 • From date of randomization, every two weeks, assessed up to 8 weeks. Adverse events were only collected for the pramipexole group.
Nervous system disorders restless leg	14.3% 1/7 • Number of events 1 • From date of randomization, every two weeks, assessed up to 8 weeks. Adverse events were only collected for the pramipexole group.
Psychiatric disorders odd thoughts	14.3% 1/7 • Number of events 1 • From date of randomization, every two weeks, assessed up to 8 weeks. Adverse events were only collected for the pramipexole group.
Nervous system disorders insomnia	14.3% 1/7 • Number of events 1 • From date of randomization, every two weeks, assessed up to 8 weeks. Adverse events were only collected for the pramipexole group.

Additional Information

Dr. Jennifer Keller

Stanford University

Phone: 650-724-0070

Email: jkeller@stanford.edu

Results disclosure agreements

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