Trial Outcomes & Findings for Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation (NCT NCT01134731)

Results Overview

The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

baseline to 12 weeks

Results posted on

2016-03-03

Participant Flow

Participants were male and female, aged 19- 65 years old, recruited as outpatients from the general public.

Participant milestones

Participant milestones
Measure	Paliperidone dose escalation, levels 1-5 daily dosing range from 1-5 mg	Lithium mood stabilizer dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)	Placebo 1-5 capsules
Overall Study STARTED	23	21	10
Overall Study COMPLETED	10	10	2
Overall Study NOT COMPLETED	13	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone dose escalation, levels 1-5 daily dosing range from 1-5 mg	Lithium mood stabilizer dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)	Placebo 1-5 capsules
Overall Study Adverse Event	3	2	1
Overall Study Physician Decision	2	2	2
Overall Study Lack of Efficacy	0	0	1
Overall Study Withdrawal by Subject	3	3	1
Overall Study Lost to Follow-up	5	4	3

Baseline Characteristics

Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone 1-5mg n=23 Participants daily	Lithium 600-1500mg n=21 Participants daily	Placebo 1-5 Capsules n=10 Participants 12 weeks	Total n=54 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	54 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	23 participants n=5 Participants	21 participants n=7 Participants	10 participants n=5 Participants	54 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.

Outcome measures

Outcome measures
Measure	Paliperidone n=23 Participants dose escalation , levels 1-5 daily dosing ranged from 1-5mg paliperidone: 1-5 mg qd	Lithium n=21 Participants dose escalation, level 1-5 daily dosing 300-1500mg lithium: 300-1500mg QD	Placebo n=10 Participants placebo comparator, 1-5 capsules
Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment	22.1 units on a scale Standard Deviation 8.6	22.1 units on a scale Standard Deviation 8.6	21.3 units on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: baseline to 12 weeks

The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs. It has 10 items (subscales) ranging from 0-6. Therefore the total score ranges from 0-60, with lower scores indicating better outcomes. The subscales were summed for a total score.

Outcome measures

Outcome measures
Measure	Paliperidone n=23 Participants dose escalation , levels 1-5 daily dosing ranged from 1-5mg paliperidone: 1-5 mg qd	Lithium n=21 Participants dose escalation, level 1-5 daily dosing 300-1500mg lithium: 300-1500mg QD	Placebo n=10 Participants placebo comparator, 1-5 capsules
Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment	37.5 units on a scale Standard Deviation 5.6	39.6 units on a scale Standard Deviation 4.1	39.2 units on a scale Standard Deviation 8.1

Adverse Events

Paliperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lithium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Richard Shelton

UAB

Phone: 205-934-2484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60