Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

NCT02382848 | Completed Results

• 1 other identifier: 00001746
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic; Bulimia Nervosa

Keywords

Eating Disorders; Bulimia Nervosa; Nightmares; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  3 weeks

• Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions

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

  3 weeks

Secondary Outcomes (4)

• Decrease in Bulimia Symptoms

  3 weeks

• Decrease in Total CAPS Score (PTSD)

  3 weeks

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

  3 weeks

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

  3 weeks

Study Arms (2)

Prazosin, Then Placebo

ACTIVE COMPARATOR

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

Drug: Prazosin; Drug: Placebo

Placebo, Then Prazosin

PLACEBO COMPARATOR

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.

Drug: Prazosin; Drug: Placebo

Interventions

Prazosin DRUG

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.

Prazosin, Then Placebo

Placebo DRUG

Prazosin-matched placebo pill

Prazosin, Then Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine, Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (11)

• Aurora RN, Zak RS, Auerbach SH, Casey KR, Chowdhuri S, Karippot A, Maganti RK, Ramar K, Kristo DA, Bista SR, Lamm CI, Morgenthaler TI; Standards of Practice Committee; American Academy of Sleep Medicine. Best practice guide for the treatment of nightmare disorder in adults. J Clin Sleep Med. 2010 Aug 15;6(4):389-401.

  PMID: 20726290 BACKGROUND

• Singareddy R, Krishnamurthy VB, Vgontzas AN, Fernandez-Mendoza J, Calhoun SL, Shaffer ML, Bixler EO. Subjective and objective sleep and self-harm behaviors in young children: a general population study. Psychiatry Res. 2013 Oct 30;209(3):549-53. doi: 10.1016/j.psychres.2013.03.036. Epub 2013 Apr 23.

  PMID: 23623452 BACKGROUND

• Dansky BS, Brewerton TD, Kilpatrick DG, O'Neil PM. The National Women's Study: relationship of victimization and posttraumatic stress disorder to bulimia nervosa. Int J Eat Disord. 1997 Apr;21(3):213-28. doi: 10.1002/(sici)1098-108x(199704)21:33.0.co;2-n.

  PMID: 9097195 BACKGROUND

• Mitchell KS, Mazzeo SE, Schlesinger MR, Brewerton TD, Smith BN. Comorbidity of partial and subthreshold ptsd among men and women with eating disorders in the national comorbidity survey-replication study. Int J Eat Disord. 2012 Apr;45(3):307-15. doi: 10.1002/eat.20965. Epub 2011 Oct 19.

  PMID: 22009722 BACKGROUND

• Gleaves DH, Eberenz KP, May MC. Scope and significance of posttraumatic symptomatology among women hospitalized for an eating disorder. Int J Eat Disord. 1998 Sep;24(2):147-56. doi: 10.1002/(sici)1098-108x(199809)24:23.0.co;2-e.

  PMID: 9697013 BACKGROUND

• Bicanic IA, Postma RM, Sinnema G, De Roos C, Olff M, Van Wesel F, Van de Putte EM. Salivary cortisol and dehydroepiandrosterone sulfate in adolescent rape victims with post traumatic stress disorder. Psychoneuroendocrinology. 2013 Mar;38(3):408-15. doi: 10.1016/j.psyneuen.2012.06.015. Epub 2012 Aug 4.

  PMID: 22867760 BACKGROUND

• Vgontzas AN, Tsigos C, Bixler EO, Stratakis CA, Zachman K, Kales A, Vela-Bueno A, Chrousos GP. Chronic insomnia and activity of the stress system: a preliminary study. J Psychosom Res. 1998 Jul;45(1):21-31. doi: 10.1016/s0022-3999(97)00302-4.

  PMID: 9720852 BACKGROUND

• Lester NA, Keel PK, Lipson SF. Symptom fluctuation in bulimia nervosa: relation to menstrual-cycle phase and cortisol levels. Psychol Med. 2003 Jan;33(1):51-60. doi: 10.1017/s0033291702006815.

  PMID: 12537036 BACKGROUND

• Ross RJ, Gresch PJ, Ball WA, Sanford LD, Morrison AR. REM sleep inhibition by desipramine: evidence for an alpha-1 adrenergic mechanism. Brain Res. 1995 Dec 1;701(1-2):129-34. doi: 10.1016/0006-8993(95)00984-x.

  PMID: 8925274 BACKGROUND

• Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.

  PMID: 17868655 BACKGROUND

• Germain A, Richardson R, Moul DE, Mammen O, Haas G, Forman SD, Rode N, Begley A, Nofzinger EA. Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans. J Psychosom Res. 2012 Feb;72(2):89-96. doi: 10.1016/j.jpsychores.2011.11.010. Epub 2011 Dec 20.

  PMID: 22281448 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Bulimia Nervosa; Feeding and Eating Disorders

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Fauzia Mahr
• Organization: Penn State University College of Medicine

fmahr@pennstatehealth.psu.edu

717 531-8133

Study Officials

• Fauzia Mahr

  Penn State College of Medicine, Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 9, 2015
• Study Start: July 1, 2015
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Locations

US (1)