Trial Outcomes & Findings for KAP for Depression in Abstinent Opioid Users (NCT NCT05193318)
NCT ID: NCT05193318
Last Updated: 2024-05-06
Results Overview
Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide. Lower scores are better (less depression).
TERMINATED
PHASE2
5 participants
Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
2024-05-06
Participant Flow
Intended total recruitment was 10 participants, however study was concluded after a total of 5 participants were recruited.
Participant milestones
| Measure |
Ketamine-assisted Psychotherapy
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Acute Intervention (Weeks 1-9 of Study)
STARTED
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5
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Acute Intervention (Weeks 1-9 of Study)
COMPLETED
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4
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Acute Intervention (Weeks 1-9 of Study)
NOT COMPLETED
|
1
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|
Follow-up Phase (Through Week 16)
STARTED
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4
|
|
Follow-up Phase (Through Week 16)
COMPLETED
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3
|
|
Follow-up Phase (Through Week 16)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ketamine-assisted Psychotherapy
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Acute Intervention (Weeks 1-9 of Study)
Physician Decision
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1
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Follow-up Phase (Through Week 16)
Lost to Follow-up
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1
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Baseline Characteristics
KAP for Depression in Abstinent Opioid Users
Baseline characteristics by cohort
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Age, Continuous
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31.2 years
STANDARD_DEVIATION 8.1 • n=99 Participants
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Sex: Female, Male
Female
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4 Participants
n=99 Participants
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Sex: Female, Male
Male
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1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Sexual orientation
Heterosexual
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3 Participants
n=99 Participants
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|
Sexual orientation
Homosexual
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1 Participants
n=99 Participants
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|
Sexual orientation
Bisexual
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1 Participants
n=99 Participants
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MADRS baseline
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34.0 units on a scale
STANDARD_DEVIATION 6.0 • n=99 Participants
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BDI Baseline
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42.8 units on a scale
STANDARD_DEVIATION 7.7 • n=99 Participants
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GAD-7 Baseline
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18.4 units on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
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PRIMARY outcome
Timeframe: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide. Lower scores are better (less depression).
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Montgomery Asberg Depression Rating Scale
Week 1
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-1.75 score on a scale
Standard Deviation 3.5
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Montgomery Asberg Depression Rating Scale
Week 2
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-3.25 score on a scale
Standard Deviation 3.0
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Montgomery Asberg Depression Rating Scale
Week 3
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-7.25 score on a scale
Standard Deviation 7.27
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Montgomery Asberg Depression Rating Scale
Week 4
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-11.75 score on a scale
Standard Deviation 7.37
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Montgomery Asberg Depression Rating Scale
Week 5
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-9 score on a scale
Standard Deviation 6.98
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Montgomery Asberg Depression Rating Scale
Week 6
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-18.3 score on a scale
Standard Deviation 6.18
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Montgomery Asberg Depression Rating Scale
Week 7
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-19 score on a scale
Standard Deviation 4.83
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Montgomery Asberg Depression Rating Scale
Week 8
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-20 score on a scale
Standard Deviation 6.32
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Montgomery Asberg Depression Rating Scale
Week 9
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-15.5 score on a scale
Standard Deviation 7.55
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Montgomery Asberg Depression Rating Scale
Week 10
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-10.7 score on a scale
Standard Deviation 12.7
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Montgomery Asberg Depression Rating Scale
Week 12
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-8.33 score on a scale
Standard Deviation 18.15
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Montgomery Asberg Depression Rating Scale
Week 16
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-10.67 score on a scale
Standard Deviation 15.82
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SECONDARY outcome
Timeframe: Change from baseline measured at week 1-9, 10, 12, and 16Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Beck Depression Inventory
Week 1
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-1.6 score on a scale
Standard Deviation 1.7
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Beck Depression Inventory
Week 2
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-6.4 score on a scale
Standard Deviation 5.0
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Beck Depression Inventory
Week 3
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-8.8 score on a scale
Standard Deviation 11.3
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Beck Depression Inventory
Week 4
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-11.8 score on a scale
Standard Deviation 9.8
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Beck Depression Inventory
Week 5
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-9 score on a scale
Standard Deviation 12.2
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Beck Depression Inventory
Week 6
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-13 score on a scale
Standard Deviation 9.1
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Beck Depression Inventory
Week 7
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-15.5 score on a scale
Standard Deviation 8.5
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Beck Depression Inventory
Week 8
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-18 score on a scale
Standard Deviation 9.6
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Beck Depression Inventory
Week 9
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-17.3 score on a scale
Standard Deviation 10.3
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Beck Depression Inventory
Week 10
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-15.3 score on a scale
Standard Deviation 9.5
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Beck Depression Inventory
Week 12
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-13.7 score on a scale
Standard Deviation 16.3
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Beck Depression Inventory
Week 16
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-16.7 score on a scale
Standard Deviation 9.9
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SECONDARY outcome
Timeframe: Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Measure of subjective level of opioid craving; maximum score of 100 and minimum score of 0 with higher scores meaning worse outcome (more cravings)
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Visual Analog Scale (VAS)
Week 1
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5 score on a scale
Standard Deviation 17.97
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Visual Analog Scale (VAS)
Week 2
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5 score on a scale
Standard Deviation 37.3
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Visual Analog Scale (VAS)
Week 3
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9.25 score on a scale
Standard Deviation 43.14
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Visual Analog Scale (VAS)
Week 4
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4.75 score on a scale
Standard Deviation 47.77
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Visual Analog Scale (VAS)
Week 5
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10 score on a scale
Standard Deviation 49.48
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Visual Analog Scale (VAS)
Week 6
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-1.25 score on a scale
Standard Deviation 38.43
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Visual Analog Scale (VAS)
Week 7
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-1.75 score on a scale
Standard Deviation 33.09
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Visual Analog Scale (VAS)
Week 8
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1.25 score on a scale
Standard Deviation 36.55
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Visual Analog Scale (VAS)
Week 9
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-6 score on a scale
Standard Deviation 38.17
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Visual Analog Scale (VAS)
Week 10
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-2 score on a scale
Standard Deviation 55.03
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Visual Analog Scale (VAS)
Week 12
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-4.33 score on a scale
Standard Deviation 54.63
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Visual Analog Scale (VAS)
Week 16
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-11 score on a scale
Standard Deviation 42.58
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SECONDARY outcome
Timeframe: Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16.Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Generalized Anxiety Disorder-7 (GAD-7)
Week 1
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-2.2 score on a scale
Standard Deviation 3.35
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Generalized Anxiety Disorder-7 (GAD-7)
Week 2
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-4.2 score on a scale
Standard Deviation 3.11
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Generalized Anxiety Disorder-7 (GAD-7)
Week 3
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-6.75 score on a scale
Standard Deviation 4.72
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Generalized Anxiety Disorder-7 (GAD-7)
Week 4
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-6.5 score on a scale
Standard Deviation 3.11
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Generalized Anxiety Disorder-7 (GAD-7)
Week 5
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-6.25 score on a scale
Standard Deviation 3.59
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Generalized Anxiety Disorder-7 (GAD-7)
Week 6
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-8.75 score on a scale
Standard Deviation 4.43
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Generalized Anxiety Disorder-7 (GAD-7)
Week 7
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-7 score on a scale
Standard Deviation 5.03
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Generalized Anxiety Disorder-7 (GAD-7)
Week 8
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-9 score on a scale
Standard Deviation 3.37
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Generalized Anxiety Disorder-7 (GAD-7)
Week 9
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-8.75 score on a scale
Standard Deviation 4.92
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Generalized Anxiety Disorder-7 (GAD-7)
Week 10
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-6.33 score on a scale
Standard Deviation 4.16
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Generalized Anxiety Disorder-7 (GAD-7)
Week 12
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-8.33 score on a scale
Standard Deviation 6.11
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Generalized Anxiety Disorder-7 (GAD-7)
Week 16
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-9 score on a scale
Standard Deviation 5
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SECONDARY outcome
Timeframe: Measured at week 1-8Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense perceptual experience. Total scores are presented as an average (mean) of the 30 item scale, each of which are rated out of 5. Scale is ordered as follows (in reference to magnitude of various perceptual experiences during acute ketamine session): 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4).
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Mystical Experience Questionnaire (MEQ)
Week 7
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4.28 score on a scale
Standard Deviation 0.55
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Mystical Experience Questionnaire (MEQ)
Week 8
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3.9 score on a scale
Standard Deviation 0.78
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Mystical Experience Questionnaire (MEQ)
Week 3
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3.55 score on a scale
Standard Deviation 0.81
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Mystical Experience Questionnaire (MEQ)
Week 4
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3.54 score on a scale
Standard Deviation 0.81
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Mystical Experience Questionnaire (MEQ)
Week 5
|
3.88 score on a scale
Standard Deviation 0.87
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Mystical Experience Questionnaire (MEQ)
Week 6
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3.25 score on a scale
Standard Deviation 0.84
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Mystical Experience Questionnaire (MEQ)
Week 1
|
2.96 score on a scale
Standard Deviation 1.20
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Mystical Experience Questionnaire (MEQ)
Week 2
|
2.32 score on a scale
Standard Deviation 1.37
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SECONDARY outcome
Timeframe: Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Measure of pain. Sub-scale 3 specifically was reported for this outcome. Subjects were asked: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours"; maximum score of 10 and minimum of 0 with higher scores indicating worse outcome (more pain) and a score of 0 indicating best outcome (no pain).
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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Brief Pain Inventory (BPI)
Baseline
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1.4 score on a scale
Standard Deviation 1.95
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Brief Pain Inventory (BPI)
Week 1
|
1.6 score on a scale
Standard Deviation 2.30
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Brief Pain Inventory (BPI)
Week 2
|
1.2 score on a scale
Standard Deviation 2.17
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Brief Pain Inventory (BPI)
Week 3
|
0.33 score on a scale
Standard Deviation 0.58
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Brief Pain Inventory (BPI)
Week 4
|
0 score on a scale
Standard Deviation 0
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|
Brief Pain Inventory (BPI)
Week 5
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 6
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 7
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 8
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 9
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 10
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (BPI)
Week 12
|
0 score on a scale
Standard Deviation 0
|
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Brief Pain Inventory (BPI)
Week 16
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Measured at week 1-9, 10, 12, and 16Population: Includes participants with available data. Four patient endorses trauma and completed PCL at least once. One participant inconsistently endorsed trauma depending on assessment week, leading to variation in number of participants analyzed each week. One participant dropped out after week 2, another failed to follow-up after week 9.
Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=4 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
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PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 1
|
64 score on a scale
Standard Deviation 7.55
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 2
|
54 score on a scale
Standard Deviation 17.08
|
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PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 3
|
42.33 score on a scale
Standard Deviation 19.09
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 4
|
45.33 score on a scale
Standard Deviation 18.04
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 5
|
44 score on a scale
Standard Deviation 21.21
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 6
|
32.33 score on a scale
Standard Deviation 18.93
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 7
|
37 score on a scale
Standard Deviation 31.11
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 8
|
36 score on a scale
Standard Deviation 19.80
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 9
|
37 score on a scale
Standard Deviation 25.46
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 10
|
40.5 score on a scale
Standard Deviation 28.99
|
|
PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 12
|
39 score on a scale
Standard Deviation 33.94
|
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PTSD Checklist (PCL-5; PTSD Checklist 5)
Week 16
|
38.5 score on a scale
Standard Deviation 27.58
|
SECONDARY outcome
Timeframe: Measured at week 1-9, 10, 12, and 16Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
Measure of Substance Use; maximum number of substance use days per week is 7 and minimum is 0 with higher number indicating worse outcomes (more substance use)
Outcome measures
| Measure |
Ketamine-assisted Psychotherapy
n=5 Participants
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
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|---|---|
|
Timeline Follow-back (TLFB)
Week 1
|
0.6 days per week
Standard Deviation 1.34
|
|
Timeline Follow-back (TLFB)
Week 2
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 3
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 4
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 5
|
1 days per week
Standard Deviation 2
|
|
Timeline Follow-back (TLFB)
Week 6
|
0.35 days per week
Standard Deviation 0.7
|
|
Timeline Follow-back (TLFB)
Week 7
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 8
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 9
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 10
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 12
|
0 days per week
Standard Deviation 0
|
|
Timeline Follow-back (TLFB)
Week 16
|
0 days per week
Standard Deviation 0
|
Adverse Events
Ketamine-assisted Psychotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine-assisted Psychotherapy
n=5 participants at risk
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 6 • 16 weeks after initiation of acute intervention
|
Additional Information
Eric Dobson, MD (principal nvestigator)
Metrohealth Hospital System (formerly employee of Medical University of South Carolina)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place