Trial Outcomes & Findings for Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism (NCT NCT00463346)

NCT ID: NCT00463346

Last Updated: 2020-03-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-03-31

Participant Flow

Participant milestones

Measure	Acamprosate Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
Overall Study STARTED	12	11
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Acamprosate Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Baseline characteristics by cohort

Measure	Acamprosate n=12 Participants Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo n=11 Participants Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Total n=23 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	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.27 years STANDARD_DEVIATION 9.24 • n=5 Participants	49.18 years STANDARD_DEVIATION 4.64 • n=7 Participants	50.73 years STANDARD_DEVIATION 7.31 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Acamprosate n=12 Participants Acamprosate 1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo n=11 Participants Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
Number of Drinking Days	10.7 days Standard Deviation 17.11	7.6 days Standard Deviation 11.5

PRIMARY outcome

Timeframe: 12 weeks

The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.

Outcome measures

Measure	Acamprosate n=12 Participants Acamprosate 1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo n=11 Participants Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
Psychotic Symptoms - Measured Using the PANSS PANSS negative symptoms	13.476 units on a scale Standard Error 1.388	15.971 units on a scale Standard Error 1.790
Psychotic Symptoms - Measured Using the PANSS PANSS general symptoms	28.083 units on a scale Standard Error 2.179	29.33 units on a scale Standard Error 2.345
Psychotic Symptoms - Measured Using the PANSS PANSS positive symptoms	14.514 units on a scale Standard Error 1.263	14.362 units on a scale Standard Error 1.352

Adverse Events

Acamprosate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acamprosate n=12 participants at risk Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.	Placebo n=11 participants at risk placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
General disorders Hospitalized for fainting and vomiting	0.00% 0/12	9.1% 1/11 • Number of events 1
Nervous system disorders Seizure	0.00% 0/12	9.1% 1/11 • Number of events 1
Psychiatric disorders Hospitalization for psychiatric symptoms	8.3% 1/12 • Number of events 1	0.00% 0/11

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Ralevski

Yale University School Of Medicine Department of Psychiatry

Phone: 2039325711

Email: elizabeth.ralevski@yale.edu

Results disclosure agreements

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