Trial Outcomes & Findings for Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients. (NCT NCT00725920)

NCT ID: NCT00725920

Last Updated: 2014-08-26

Results Overview

The Clinician-Administered PTSD Scale (CAPS) \[33\] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above. CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28). CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 week
• Results posted on: 2014-08-26

Participant Flow

Participant milestones

Measure	Topiramate patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).	Control Group patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
Overall Study STARTED	17	18
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Topiramate patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).	Control Group patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
Overall Study Lack of Efficacy	3	6

Baseline Characteristics

Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.

Baseline characteristics by cohort

Measure	Topiramate n=17 Participants patients receiving the active drug: topiramate	Control Group n=18 Participants patients received pills content placebo, that were identical to the pills content active drug	Total n=35 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	17 Participants n=5 Participants	18 Participants n=7 Participants	35 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	43.7 years STANDARD_DEVIATION 13.44 • n=5 Participants	36.5 years STANDARD_DEVIATION 7.97 • n=7 Participants	37.54 years STANDARD_DEVIATION 12.08 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Brazil	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants
Clinician Administered Posttraumatic Scale (CAPS) Reexperiencing symptoms (CAPS-B)	23.05 scores on a scale STANDARD_DEVIATION 5.88 • n=5 Participants	21.21 scores on a scale STANDARD_DEVIATION 7.15 • n=7 Participants	22.84 scores on a scale STANDARD_DEVIATION 3.85 • n=5 Participants
Clinician Administered Posttraumatic Scale (CAPS) Avoidance/numbing symptoms (CAPS-C)	31.58 scores on a scale STANDARD_DEVIATION 7.13 • n=5 Participants	24.78 scores on a scale STANDARD_DEVIATION 11.30 • n=7 Participants	28.6 scores on a scale STANDARD_DEVIATION 4.79 • n=5 Participants
Clinician Administered Posttraumatic Scale (CAPS) Hyperarousal symptoms (CAPS-D)	24.11 scores on a scale STANDARD_DEVIATION 5.69 • n=5 Participants	20.14 scores on a scale STANDARD_DEVIATION 8.29 • n=7 Participants	22.03 scores on a scale STANDARD_DEVIATION 3.8 • n=5 Participants
Clinician Administered Posttraumatic Scale (CAPS) Total CAPS	79.64 scores on a scale STANDARD_DEVIATION 12.03 • n=5 Participants	64.33 scores on a scale STANDARD_DEVIATION 22 • n=7 Participants	72.43 scores on a scale STANDARD_DEVIATION 16.73 • n=5 Participants

PRIMARY outcome

Timeframe: 12 week

The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.

CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).

CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity.

Outcome measures

Measure	Topiramate n=17 Participants patients receiving the active drug: topiramate	Control Group n=18 Participants patients received pills content placebo, that were identical to the pills content active drug
Clinician Administered Posttraumatic Stress Disorder Scale	30.41 Total CAPS score Standard Deviation 30.90	35.78 Total CAPS score Standard Deviation 33.76

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Topiramate n=17 participants at risk patients receiving the active drug: topiramate	Control Group n=18 participants at risk patients received pills content placebo, that were identical to the pills content active drug
Nervous system disorders somnolence	23.5% 4/17 • Number of events 4 • 12 weeks	33.3% 6/18 • Number of events 6 • 12 weeks
Psychiatric disorders insomnia	23.5% 4/17 • Number of events 4 • 12 weeks	5.6% 1/18 • Number of events 1 • 12 weeks
Nervous system disorders headache	11.8% 2/17 • Number of events 2 • 12 weeks	22.2% 4/18 • Number of events 4 • 12 weeks
Nervous system disorders paresthesia	17.6% 3/17 • Number of events 3 • 12 weeks	0.00% 0/18 • 12 weeks
Psychiatric disorders irritability	11.8% 2/17 • Number of events 2 • 12 weeks	0.00% 0/18 • 12 weeks
Gastrointestinal disorders dyspepsia	17.6% 3/17 • Number of events 3 • 12 weeks	0.00% 0/18 • 12 weeks
Psychiatric disorders difficulty of concentration	11.8% 2/17 • Number of events 2 • 12 weeks	0.00% 0/18 • 12 weeks

Additional Information

Marcelo F Mello

Federal University of Sao Paulo

Phone: 55 11 50822860

Email: mf-mello@uol.com.br

Results disclosure agreements

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