Trial Outcomes & Findings for Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD (NCT NCT02382848)

Last Updated: 2019-07-16

Results Overview

The individual question about frightening dreams from the Nightmares Subscale of a self-administered questionnaire (Sleep-50 Questionnaire), will be used to determine if there is a decrease in frequency of nightmares in patients undergoing drug intervention. For each question, respondents are provided with a scale ranging from 1 ("not at all") to 4 ("very much") and are asked to indicate the extent to which the statement has matched their experience over the study time frame. The scale values range from 1-4, where a lower value indicates lower frequency of nightmares. A higher score is a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

3 weeks

Results posted on

2019-07-16

Participant Flow

1 participant consented to the study, but decided not to continue before completing screening measures due to scheduling difficulties.

Participant milestones

Participant milestones
Measure	Prazosin, Then Placebo A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily. After a washout period of 1 week, they then will receive matching placebo pill.	Placebo, Then Pazosin Placebo will be given for a 3 consecutive week period during the 7 week study period. After a washout period of 1 week, they then will be given Prazosin matched pill (1mg capsule). Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily. Placebo: Placebo (sugar pill) is used for 3 weeks.
First Intervention (3 Weeks) STARTED	3	5
First Intervention (3 Weeks) COMPLETED	3	5
First Intervention (3 Weeks) NOT COMPLETED	0	0
Washout (1 Week) STARTED	3	5
Washout (1 Week) COMPLETED	3	5
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention (3 Weeks) STARTED	3	5
Second Intervention (3 Weeks) COMPLETED	3	5
Second Intervention (3 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=8 Participants All participants received Prazosin (1mg capsule) and Placebo during the course of the research study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Weight (kg)	60.6 Weight in (kg) STANDARD_DEVIATION 10.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome measures
Measure	Prazosin n=8 Participants A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.	Placebo n=8 Participants Placebo will be given for a 3 consecutive week period during the 7 week study period. Placebo: Placebo (sugar pill) is used for 3 weeks.
Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire	2.25 score on a scale Standard Error .37	2.75 score on a scale Standard Error .25

PRIMARY outcome

Timeframe: 3 weeks

Population: This study was designed to include a second phase involving polysomnography in 2 participants if there was enough signal efficacy found based on subjective measures. The second phase was not done, therefore no data was analyzed for this outcome measure.

PSG (Polysomnogram) will be used in 2 participants to determine if there is a decrease in REM density in patients undergoing drug intervention.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

EDI-3 (Eating Disorder Inventory 3 Scale) is a pencil and paper test consisting of 91 items and 12 sub-scales. The main scales are the drive for thinness and the bulimia scales, the remaining sub-scales are: low self-esteem, body dissatisfaction, maturity fears, personal alienation, interpersonal alienation, interpersonal insecurity, perfectionism, interoceptive deficits, emotional dysregulation, and asceticism. The response options are based on a 6-point Likert-type scale are: Always, Usually, Often, Sometimes, Rarely, and Never. There are six composite scores, 12 primary scores, and three response style validity indicators. Software is used to calculate the raw scores, composite scores, validity scale scores and the T-scores. The t-score for the Bulimia scale will be used for this analysis with a range of 22-66. Higher scores indicate the likelihood of an eating disorder. A higher t-score on the bulimia scale indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Prazosin n=8 Participants A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.	Placebo n=8 Participants Placebo will be given for a 3 consecutive week period during the 7 week study period. Placebo: Placebo (sugar pill) is used for 3 weeks.
Decrease in Bulimia Symptoms	43.1 T-Score Standard Error 5.0	38.6 T-Score Standard Error 4.8

SECONDARY outcome

Timeframe: 3 weeks

The CAPS (Clinician administered PTSD) rating scale consists of 30 questions rated on a 0-4 point scoring system and patient interview will be used to determine if there is a decrease in PTSD Symptoms among participants undergoing drug intervention. 17 of these questions are used to calculate the total severity score used in this analysis. This is done by summing the frequency and intensity ratings (each ranging from 0-4) for each of the 17 questions. The total severity score can have a range of 0-136. A higher score on this scale indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Prazosin n=8 Participants A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.	Placebo n=8 Participants Placebo will be given for a 3 consecutive week period during the 7 week study period. Placebo: Placebo (sugar pill) is used for 3 weeks.
Decrease in Total CAPS Score (PTSD)	65.5 score on a scale Standard Error 9.1	79.8 score on a scale Standard Error 12.9

SECONDARY outcome

Timeframe: 3 weeks

Rating scales and subject interview will be used to determine if there is a decrease in depressed mood among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Depressed Mood, measured on a 5-point scale) where a higher score again indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Prazosin n=8 Participants A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.	Placebo n=8 Participants Placebo will be given for a 3 consecutive week period during the 7 week study period. Placebo: Placebo (sugar pill) is used for 3 weeks.
Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview	1.4 score on a scale Standard Error 0.4	1.3 score on a scale Standard Error .50

SECONDARY outcome

Timeframe: 3 weeks

Rating scales and subject interview will be used to determine if there is a decrease in self harm among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Self Harm, measured on a 5-point scale) where a higher score again indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Prazosin n=8 Participants A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.	Placebo n=8 Participants Placebo will be given for a 3 consecutive week period during the 7 week study period. Placebo: Placebo (sugar pill) is used for 3 weeks.
Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview	0.5 score on a scale Standard Error 0.4	.1 score on a scale Standard Error .1

Adverse Events

Prazosin

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. Fauzia Mahr

Penn State University College of Medicine

Phone: 717 531-8133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place