Trial Outcomes & Findings for NMDA Antagonists in Bipolar Depression (NCT NCT01833897)

NCT ID: NCT01833897

Last Updated: 2016-06-01

Results Overview

Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-06-01

Participant Flow

Participant milestones

Measure	Ketamine and DCS Treatment Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ketamine and DCS Treatment Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Study Lack of Efficacy	1

Baseline Characteristics

NMDA Antagonists in Bipolar Depression

Baseline characteristics by cohort

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Montgomery Asberg Depression Rating scale	29 units on a scale STANDARD_DEVIATION 6 • n=5 Participants
Hamilton Depression Rating Scale (HAM-D)	18.8 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants
Hamilton Depression Rating Scale (HAM-D) suicide item	1.25 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Loss of Motivated Behavior HAM-D Factor	5 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Hamilton Anxiety Rating Scale (HAM-A)	12.6 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants
Beck's depression inventory	31.4 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants
Time of treatment resistance	3.3 Months STANDARD_DEVIATION 4 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: bipolar depression

Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression

≥ 23 = Very Severe Depression

Outcome measures

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Hamilton Depression Rating Scale (HAM-D)	9.5 units on a scale (final score) Standard Deviation 7

SECONDARY outcome

Timeframe: 8 weeks

Population: bipolar depression

includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms

Outcome measures

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Loss of Motivated Behavior HAM-D Factor	1.6 units on a scale (final score) Standard Deviation 1.9

SECONDARY outcome

Timeframe: 8 weeks

Ham-D suicide item: range 0-4, higher scores indicate worse symptoms

Outcome measures

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
HAM-D Suicide Item	0.3 units on a scale (final) Standard Deviation 0.5

SECONDARY outcome

Timeframe: 8 weeks

Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Outcome measures

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Hamilton Anxiety Scale	6.4 units on a scale (final score) Standard Deviation 5

SECONDARY outcome

Timeframe: 8 weeks

Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Outcome measures

Measure	Ketamine and DCS Treatment n=8 Participants Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Beck's Depression Inventory	10.8 units on a scale (final score) Standard Deviation 9.2

Adverse Events

Ketamine and DCS Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketamine and DCS Treatment n=8 participants at risk Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Nervous system disorders headache	25.0% 2/8 • Number of events 2
Nervous system disorders sedation	37.5% 3/8 • Number of events 3
Eye disorders phosphenes	12.5% 1/8 • Number of events 1
Psychiatric disorders hypomania	12.5% 1/8 • Number of events 1

Additional Information

Joshua Kantrowitz

New York State Psychiatric Institute

Phone: 646-774-6738

Email: jkantrowitz@nki.rfmh.org

Results disclosure agreements

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