Trial Outcomes & Findings for Effects of Pentazocine Versus Lorazepam on Manic Symptoms (NCT NCT00431184)

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. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention

Results posted on

2019-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Pentazocine Then Lorazepam In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.	Lorazepam Then Pentazocine In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
1st Intervention (Day 1) STARTED	10	9
1st Intervention (Day 1) COMPLETED	10	9
1st Intervention (Day 1) NOT COMPLETED	0	0
Second Intervention (Day 2) STARTED	10	9
Second Intervention (Day 2) COMPLETED	10	9
Second Intervention (Day 2) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pentazocine Then Lorazepam n=10 Participants In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.	Lorazepam Then Pentazocine n=9 Participants In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention

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. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.

Outcome measures

Outcome measures
Measure	Pentazocine n=19 Participants Subjects received 50mg of pentazocine	Lorazepam n=19 Participants Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
Mania Acute Rating Scale (MACS)	3.9 units on a scale Interval 0.7 to 7.1	6.4 units on a scale Interval 3.4 to 9.5

SECONDARY outcome

Timeframe: at the time of administration of intervention and 5 hours following administration of intervention

The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.

Outcome measures

Outcome measures
Measure	Pentazocine n=19 Participants Subjects received 50mg of pentazocine	Lorazepam n=19 Participants Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
Young Mania Rating Scale (YMRS)	23.0 units on a scale Interval 16.6 to 29.4	22.6 units on a scale Interval 15.9 to 29.3

Adverse Events

Pentazocine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lorazepam

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

Beth Murphy MD

McLean Hospital

Phone: 617-855-2297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place