Evaluation of clonidine and doxazosin for treating nightmares in adults with Post-traumatic Stress Disorder

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What is this study about?

This study focuses on treating nightmares in patients with Posttraumatic Stress Disorder (PTSD). PTSD is a mental health condition that can develop after experiencing or witnessing a traumatic event, often causing disturbing nightmares and sleep problems. The study aims to determine if two medications – clonidine and doxazosin – are more effective than placebo in reducing nightmares in PTSD patients.

The medications being tested belong to a group of drugs called alpha-adrenergic agents, which can affect how the body responds to stress. During the study, participants will receive either clonidine (0.075-0.375 mg), doxazosin (1-10 mg), or placebo in the form of capsules. The treatment period lasts for several weeks, during which the medication dose may be adjusted.

Throughout the study, participants will have their nightmare frequency and intensity monitored, along with their overall PTSD symptoms and sleep quality. The study will also track changes in depression symptoms, daily sleep patterns, and quality of life. Regular check-ups will be conducted to monitor the participants’ progress and any potential effects of the medications.

1 Initial phase – Week 1

You will receive placebo tablets (inactive medication) in swedish-orange colored capsules

This initial phase helps establish baseline measurements

2 Treatment phase – Weeks 2-11

You will be randomly assigned to receive one of three treatments:

Option 1: Clonidine tablets (75 micrograms), taken orally

Option 2: Doxazosin tablets (starting at 1 mg, may increase up to 10 mg), taken orally

Option 3: Placebo (inactive medication) in swedish-orange colored capsules

3 Assessment visits

You will attend regular assessment visits during weeks 2-9

Medical staff will evaluate your symptoms using standardized questionnaires

The final assessment will occur at week 10 (visit 9)

4 Daily monitoring

You will maintain a sleep diary throughout the study recording:

Total sleep time in minutes

Time taken to fall asleep

Time spent awake during the night

Number of nightmares (0, 1, 3, 4 or more)

Nightmare intensity on a scale from 0 (not at all) to 5 (extreme)

Sleep quality rating

5 Final evaluation

The study concludes after 10 weeks of treatment

Final assessments will measure changes in:

Frequency and intensity of nightmares

Overall PTSD (post-traumatic stress disorder) symptoms

Sleep quality

Depression levels

Quality of life indicators

Who Can Join the Study?

You must be diagnosed with posttraumatic stress disorder (PTSD) and score at least 26 points on a special assessment scale called CAPS-5
You must experience at least two nightmares per week that are moderately distressing or worse
You must be between 18 and 65 years old
You must be able to provide written consent and understand the nature and possible effects of the treatment
If you are a woman who can become pregnant, you must:
- Have a negative pregnancy test (urine or blood)
- Not be breastfeeding
- Use reliable birth control methods during the study
Your current medications must be stable, meaning:
- You have been taking the same dose for at least 4 weeks
- You have not had any recent changes in how much or how often you take your medications

Who Cannot Join the Study?

Current diagnosis of severe depression or active thoughts of self-harm
History of allergic reactions to clonidine or doxazosin
Current pregnancy or breastfeeding
Severe heart conditions or uncontrolled blood pressure
Liver or kidney disease that could affect medication processing
Current use of medications that could interact with study drugs (such as other blood pressure medications)
Substance abuse or dependence within the past 3 months
Sleep apnea (a condition where breathing repeatedly stops during sleep) or other severe sleep disorders
Participation in other clinical trials within the past 30 days
Inability to provide informed consent (understanding and agreeing to study participation)
History of fainting or severe drops in blood pressure when standing up
Serious medical conditions that are not well-controlled
Regular use of medications that affect blood pressure or heart rate
History of not following prescribed medication schedules

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Central Institute of Mental Health	Mannheim	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Ushemzzfai Msraqku Clxvbh Hfjksgghzeupwacvn	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	17.06.2022

Trial locations

Investigated drugs:

Clonidine is a medication that affects certain receptors in the brain and nervous system. It belongs to a group of drugs called alpha-agonists. In this trial, it is being studied for its potential to reduce nightmares in people with post-traumatic stress disorder (PTSD). This medication is already known to help with high blood pressure and certain attention disorders.

Doxazosin is a medication that works by relaxing blood vessels and affecting certain brain receptors. It belongs to a group of medications called alpha-blockers. While it is commonly used to treat high blood pressure and prostate problems in men, in this trial it is being tested for its ability to help reduce nightmares in people with PTSD.

Investigated diseases:

Post-traumatic stress disorder

Posttraumatic Stress Disorder – A mental health condition that develops after exposure to a traumatic event. The condition causes persistent distressing memories, nightmares, and flashbacks of the traumatic experience. People with PTSD often experience heightened anxiety, emotional numbness, and strong reactions to reminders of the trauma. Sleep problems, including recurring nightmares, are common symptoms that can significantly impact daily life. The disorder can affect both the emotional and physical responses to everyday situations, causing people to feel constantly alert and on guard.

Trial ID:

2024-517537-40-00

Protocol code:

ClonDO

NCT ID:

NCT05360953

Trial Phase:

Therapeutic exploratory (Phase II)

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Evaluation of clonidine and doxazosin for treating nightmares in adults with Post-traumatic Stress Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?