Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

Penn State Health

Status: Completed

Conditions: Bulimia Nervosa; Stress Disorders, Post-Traumatic

Treatments: Drug: Placebo; Drug: Prazosin

Study type: Interventional

Funder types: Other

Identifiers

NCT02382848

00001746

Details and patient eligibility

About

This research is being done to find out how effective Prazosin is in the treatment of bulimic patients experiencing distressing nightmares using subjective and objective measures.

Full description

To the investigators knowledge, there is no treatment trial for prazosin use in patients with bulimia nervosa struggling with nightmares, looking at either objective or subjective measures. The investigators plan to probe the effectiveness of prazosin in bulimic patients experiencing nightmares due to PTSD using both subjective and objective measures in order to improve future clinical care. The effects of prazosin on decreasing nightmares and bulimic symptoms on subjective scales and effects on sleep architecture using objective polysomnogram (PSG) measurements will help inform targeted psychopharmacologic and psychotherapeutic strategies to improve clinical care of bulimic patients struggling with distressing dreams secondary to PTSD. This study will be performed in two phases. Phase A will involve eight participants who will be tested using subjective scales (mentioned below). If Phase A data analysis leads to detection of a signal of efficacy 2 more participants will be recruited to participate in phase B of this trial using objective polysomnogram measurements. The results from this project will aid in establishing a fully powered clinical trial for treatment of nightmares in bulimic patients and improve outcomes in this high risk population.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-45
• Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD

Exclusion criteria

• Restless leg syndrome
• Narcolepsy
• Sleep Apnea
• Neurological disorders
• Pregnancy
• cardiac abnormalities
• significant electrolyte abnormalities
• Use of steroids, beta blockers, prazosin
• Alcohol/substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Prazosin, Then Placebo

Active Comparator group

Description:

Participants first received Prazosin. 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, they then receive Placebo

Treatment:

Drug: Prazosin

Drug: Prazosin

Drug: Placebo

Drug: Placebo

Placebo, Then Prazosin

Placebo Comparator group

Description:

Participants first received Placebo (matching Prazosin) for a 3 consecutive week period during the 7 week study period. After a washout period, they then received Prazosin. The starting dose of Prazosin (1mg capsule) will be given at Week # 5 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.

Treatment:

Drug: Prazosin

Drug: Prazosin

Drug: Placebo

Drug: Placebo