Trial Outcomes & Findings for A Definitive Estrogen Patch Study (ADEPT) (NCT NCT00357006)
NCT ID: NCT00357006
Last Updated: 2015-05-12
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
COMPLETED
PHASE2
180 participants
Baseline and week 8
2015-05-12
Participant Flow
Between 2006 and 2011, a total of 1858 women were assessed for eligibility, of which 204 were screened from inpatient and outpatient settings across three Australian sites (Alfred, a tertiary referral centre; Barwon, a rural centre; and Dandenong, an outer metropolitan centre) over a 5-year period and completed a 56-day trial.
Participant milestones
| Measure |
Adjunctive 200 mcg Transdermal Estradiol
Participants received daily 200mcg transdermal estradiol for 56 days.
|
Adjunctive 100 mcg Transdermal Estradiol
Participants received daily 100mcg transdermal estradiol for 56 days.
|
Placebo
Participants received daily transdermal placebo for 56 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
56
|
62
|
|
Overall Study
COMPLETED
|
60
|
51
|
59
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Adjunctive 200 mcg Transdermal Estradiol
Participants received daily 200mcg transdermal estradiol for 56 days.
|
Adjunctive 100 mcg Transdermal Estradiol
Participants received daily 100mcg transdermal estradiol for 56 days.
|
Placebo
Participants received daily transdermal placebo for 56 days.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
Baseline Characteristics
A Definitive Estrogen Patch Study (ADEPT)
Baseline characteristics by cohort
| Measure |
Adjunctive 200 mcg Transdermal Estradiol
n=62 Participants
|
Adjunctive 100 mcg Transdermal Estradiol
n=56 Participants
|
Placebo
n=62 Participants
|
Total
n=180 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
|
62 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
180 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
|
|
Age, Continuous
|
35.29 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
34.77 years
STANDARD_DEVIATION 7.28 • n=7 Participants
|
35.44 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
35.18 years
STANDARD_DEVIATION 7.96 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
180 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
Australia
|
62 participants
n=5 Participants
|
56 participants
n=7 Participants
|
62 participants
n=5 Participants
|
180 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 8The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Outcome measures
| Measure |
Adjunctive 200 mcg Transdermal Estradiol
n=62 Participants
Participants received daily 200 mcg transdermal estradiol for 56 days.
|
Adjunctive 100 mcg Transdermal Estradiol
n=56 Participants
Participants received daily 100 mcg transdermal estradiol for 56 days.
|
Placebo
n=62 Participants
Participants received daily transdermal placebo for 56 days.
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
18.24 units on a scale
Standard Deviation 5.66
|
19.18 units on a scale
Standard Deviation 5.54
|
18.18 units on a scale
Standard Deviation 5.70
|
|
Positive and Negative Syndrome Scale (PANSS)
Endpoint (day 56)
|
14.11 units on a scale
Standard Deviation 4.94
|
16.36 units on a scale
Standard Deviation 5.57
|
16.36 units on a scale
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: baseline and week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 4, 6, 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and weeks 1, 4 and 8.Outcome measures
Outcome data not reported
Adverse Events
Adjunctive 200 mcg Transdermal Estradiol
Adjunctive 100 mcg Transdermal Estradiol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof Jayashri Kulkarni
Monash Alfred Psychiatry Research Centre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place