prazosin and Sleep Wake Disorders

prazosin has been researched along with Sleep Wake Disorders in 34 studies

Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.
prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively.

Sleep Wake Disorders: Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle.

Research

Studies (34)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

CAPS Recurrent Distressing Dreams Item

Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Clinical Global Impression of Change (CGIC)

Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Pittsburgh Sleep Quality Index (PSQI)

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

CAPS Recurrent Distressing Dreams Item

Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.

Clinical Global Impression of Change

Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening. (NCT00532493)
Timeframe: This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Patient Health Questionnaire-9 (PHQ9)

Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Pittsburgh Sleep Quality Index

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

PTSD Checklist-Military Version (PCL-M) Score

Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD. (NCT00532493)
Timeframe: This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.

Quality of Life Inventory (QOLI)

Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

SF-12 Mental Standardized Score (SF-12 MCS)

Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

SF-12 Physical Standardized Score (SF-12 PCS)

Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Total CAPS Score

Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).

Decrease in Bulimia Symptoms

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. (NCT02382848)
Timeframe: 3 weeks

Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview

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. (NCT02382848)
Timeframe: 3 weeks

Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire

"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." (NCT02382848)
Timeframe: 3 weeks

Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview

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. (NCT02382848)
Timeframe: 3 weeks

Decrease in Total CAPS Score (PTSD)

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. (NCT02382848)
Timeframe: 3 weeks

Insomnia Severity Index

Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score < 8 is considered to reflect no significant insomnia. (NCT00393874)
Timeframe: Screening, Post, and Follow-up

PSG Composite Measure

"Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed.~For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep." (NCT00393874)
Timeframe: Baseline sleep study and post sleep study

PSQI

"Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality.~A score of < or = to 5 reflects good sleep quality." (NCT00393874)
Timeframe: Baseline, post, 4 months post-treatment

Sleep Diary Measures

"Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed.~Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity." (NCT00393874)
Timeframe: baseline and post

Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS

"Item B-2 recurrent distressing dreams of the event is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8." (NCT00183430)
Timeframe: Baseline to Week 8

Change in Sleep Assessed by the Pittsburgh Sleep Quality Index

Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8. (NCT00183430)
Timeframe: Baseline to Week 8

Clinical Global Impression of Change

The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8. (NCT00183430)
Timeframe: Baseline to Week 8

Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12

"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12. Minimum = 0 Maximum = 8" (NCT00202449)
Timeframe: Baseline and Week 12

Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12

The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12. (NCT00202449)
Timeframe: Baseline to Week 12

Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12

Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12. (NCT00202449)
Timeframe: Baseline to Week 12

Intensity of Suicidal Ideation

"Intensity of Suicidal Ideation was monitored over the course of the trial by the second section of the Columbia Suicide Severity Rating Scale (CSSRS). This section is only administered if the patient answers yes to the first section. The section consists of 5 questions that refer to the most severe level of ideation endorsed in the first section of the CSSRS. The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.~Only lifetime intensity of suicidal ideation was explored as the patient had no suicidal ideation from the month prior to beginning the study to the completion of the study" (NCT01917318)
Timeframe: Baseline

Aggression

Aggression was measured by the Modified Overt Aggression Scale (MOAS).This assessment measures four types of aggressive behavior (verbal, aggression against property, autoaggression, and physical aggression) . Total scores on the MOAS range from 0-40, with a higher score indicating more aggressive behavior. (NCT01917318)
Timeframe: Randomization and 8 weeks of treatment, during both treatment periods

Change in Clinician Administered PTSD Scale (CAPS) Part B and D

"The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing.~CAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms.~CAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms.~The primary endpoint was changes in CAPS part B and D after 8 weeks of treatment." (NCT01917318)
Timeframe: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.

Suicidal Behavior

The presence and severity os suicidal behavior was monitored over the course of the trial by the third section of the Columbia Suicide Severity Rating Scale (CSSRS). This sections consists of questions about 5 suicidal behaviors and non-suicidal self injurious behavior and it can be answered yes or no. The number of participants who experienced suicidal behavior is reported. (NCT01917318)
Timeframe: Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored

Suicidal Ideation

The presence of suicidal ideation was monitored over the course of the trial by the first section of the Columbia Suicide Severity Rating Scale (CSSRS). This first section of the scale consists of 5 questions that can be answered yes or no. The number of participants who reported experiencing suicidal ideation is reported. (NCT01917318)
Timeframe: Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored

ADCS-ADL-Severe

"The ADCS-ADL-Severe questionnaire is a secondary outcome measure aimed at detecting functional decline in people with severe AD. This scale is best suited for evaluating people with MMSE scores below 15/30, or equivalent. Questions are administered to a qualified caregiver informant about a set of 19 basic and instrumental ADL. Instrumental ADL are selected to be relevant to this level of severity of dementia, e.g., obtaining a beverage, turning lights on and off, turning a faucet on and off. Performance of each of these activities during the past 4 weeks, as well as the level of performance, are rated. A total score is derived by summing scores across items, and ranges from 0 (maximal impairment) to 54 (maximally independent function).~This outcome is the change from baseline to week 12." (NCT03710642)
Timeframe: 12 weeks

ADCS-Clinical Global Impression of Change in Agitation (ADCS-CGIC-A)

"The ADCS-CGIC-A is the primary outcome measure. It will be anchored to disruptive agitation, the target behaviors in this study. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a direct examination of the participant and an interview of the participant's primary caregiver and other LTC facility staff. The baseline assessment is qualitative therefore there is no score at baseline; post-baseline scores represent a change score compared to baseline.~The ADCS-CGIC-A is a 7-point scale that is structured as the clinician's assessment of change from baseline compared to the ADCS-CGIC-A Baseline Worksheet. There is no baseline score; post-baseline scores range from 1 (improvement) to 7 (worsening). A score of 1-2 indicates clinically meaningful improvement; a score of 3-5 indicates no clinically meaningful change; a score of 6-7 indicates clinically meaningful worsening." (NCT03710642)
Timeframe: From Baseline through Week 12.

Caregiver Distress on NPI/NPI-NH

"Comparison of effects on caregiver distress/occupational disruptiveness scores on the NPI/NPI-NH. Minimum score is 0 and maximum score is 60. A higher score is a worse outcome.~This outcome is the change from baseline to week 12." (NCT03710642)
Timeframe: 12 weeks

Neuropsychiatric Inventory (NPI)/Neuropsychiatry Inventory-Nursing Home Version (NPI-NH)

"The NPI was designed to characterize the neuropsychiatric symptoms and psychopathology of patients with AD and other dementias residing in the community about which information was obtained from family caregivers. The content of the questions and their scoring in the NPI-NH are identical to those of the NPI except for some slight rephrasing to be consistent with the LTC environment where information is gathered from professional caregivers. Assessment of the impact of behavioral disturbances on family and professional caregivers, is assessed by a caregiver distress scale in the NPI and an occupational disruptiveness scale in the NPI-NH; scoring of this component remains identical. Minimum score is 0 and highest score is 144. A higher score means a worse outcome.~This outcome is the change from baseline to week 12." (NCT03710642)
Timeframe: 12 weeks

Rescue Medication: Total mg Lorazepam Administered

Cumulative total dose of Lorazepam rescue medication administered during the trial. Information on the total mg rescue lorazepam administered will be collected as additional secondary outcome measures. If prazosin is more effective than placebo, it is predicted that participants randomized to prazosin will be prescribed lower cumulative mg of rescue lorazepam for management of persistent or worsening disruptive agitation. (NCT03710642)
Timeframe: 12 weeks

Responder Analysis on CGIC-A

Comparison of proportions of responders versus non responders on the ADCS-CGIC-A. Responders are defined as those with moderate or marked improvement in agitation symptoms compared to baseline assessment. (NCT03710642)
Timeframe: 12 weeks

Study Discontinuations

Cox proportional hazard modelling comparing the median time to drop out between treatment groups. (NCT03710642)
Timeframe: 12 weeks

Reviews

12 reviews available for prazosin and Sleep Wake Disorders

Trials

8 trials available for prazosin and Sleep Wake Disorders

Other Studies

14 other studies available for prazosin and Sleep Wake Disorders