Trial Outcomes & Findings for An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants (NCT NCT00591565)

NCT ID: NCT00591565

Last Updated: 2014-12-18

Results Overview

this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: baseline and 8wk
• Results posted on: 2014-12-18

Participant Flow

Patients were recruited by radio, newspaper and word of mouth

Participant milestones

Measure	Acamprosate acamprosate tablets
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Acamprosate acamprosate tablets
Overall Study lost follow up, withdrawn	5

Baseline Characteristics

An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants

Baseline characteristics by cohort

Measure	Acamprosate n=13 Participants acamprosate tablets
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8wk

Population: LOCF if two initial visits were completed

this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).

Outcome measures

Measure	Acamprosate n=8 Participants
Change From Baseline at 8 Weeks in the HAM-A Scale	6.12 units on a scale Standard Deviation 1.39

Adverse Events

Acamprosate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acamprosate n=13 participants at risk acamprosate tablets
Gastrointestinal disorders nausea	7.7% 1/13 • Number of events 1
Nervous system disorders Vivid Dreams	7.7% 1/13 • Number of events 1

Additional Information

Thomas Schwartz

SUNY Upstate

Phone: 3154643166

Email: schwartt@upstate.edu

Results disclosure agreements

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