Trial Outcomes & Findings for Effects of Pentazocine on Manic Symptoms (NCT NCT00125931)

Results Overview

Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered

Results posted on

2014-09-04

Participant Flow

Subjects were 18-60 year old male and female individuals who were currently hospitalized.

Participant milestones

Participant milestones
Measure	Treatment Group Open label group with pentazocine treatment.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Pentazocine on Manic Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=10 Participants Open label treatment with pentazocine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered

Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.

Outcome measures

Outcome measures
Measure	Open Label Group n=10 Participants Mania symptoms with pentazocine compared to baseline symptoms.
Mania Symptoms Using MACS Hour 2	18.6 units on a scale Full Range 8.9 • Interval 0.0 to 39.0
Mania Symptoms Using MACS Hour 3	11.0 units on a scale Full Range 6.9 • Interval 0.0 to 37.0

SECONDARY outcome

Timeframe: Each morning of the three-day study

Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.

Outcome measures

Outcome measures
Measure	Open Label Group n=10 Participants Mania symptoms with pentazocine compared to baseline symptoms.
YMRS Scores pre-treatment day	23.6 units on a scale Standard Deviation 8.9
YMRS Scores treatment day	22.0 units on a scale Standard Deviation 6.9
YMRS Scores post-treatment day	12.7 units on a scale Standard Deviation 8.4

Adverse Events

Open Label Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Group n=10 participants at risk Mania symptoms with pentazocine compared to baseline symptoms.
Nervous system disorders Sedation	50.0% 5/10 • Number of events 5 • 3 days: pre-treatment day, treatment day, post-treatment day
Nervous system disorders mild lightheadedness	60.0% 6/10 • Number of events 6 • 3 days: pre-treatment day, treatment day, post-treatment day
Gastrointestinal disorders upset stomach	10.0% 1/10 • Number of events 1 • 3 days: pre-treatment day, treatment day, post-treatment day

Additional Information

Beth Murphy, MD PhD

McLean Hospital

Phone: 617-855-2297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place