Identifying and Treating Depression in Hemodialysis Patients

NCT03390933 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB17-00768
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is present in about 20-30% of hemodialysis patients and is associated with morbidity and mortality. However, depression is inadequately diagnosed and treated among dialysis patients. This is due in part to the overlap between depressive symptoms (e.g. appetite change, trouble sleeping, feeling tired) and symptoms related to persistent metabolic derangements in hemodialysis patients (e.g. nausea, nocturnal cramps, feeling washed out after treatment). The overlap between depressive symptoms and dialysis-related complications makes it difficult to diagnose and therefore to treat depression. In addition, prescription of antidepressant medication may increase an already high pill burden and result in poor adherence. Moreover, the evidence base to guide depression treatment among hemodialysis patients is limited. In the investigators' previous work, they developed methods to use latent variables and structural equation modeling to isolate depressive symptoms. Other investigators have demonstrated that directly observed treatment enhances the effectiveness of tuberculosis and HIV treatment. Investigators now propose a cross-sectional study (Phase 1) followed by a single-arm clinical trial (Phase 2) at 17 dialysis facilities. The cross-sectional study will involve assessments of depressive symptoms (using the PHQ-9 screening instrument) as well as dialysis-related complications, anxiety, and quality of life (Quality of Life Questionnaire) in about 1083 patients. Investigators will then use structural equation modeling to develop and validate a hemodialysis-specific PHQ-9 (hdPHQ-9) that will isolate depressive symptoms. The trial will involve 96 patients with confirmed depression who will be assigned to directly observed weekly antidepressant treatment with fluoxetine. The primary outcome of the trial will be remission of depression at 12 weeks. The trial results will also be used to compare the responsiveness of the PHQ-9 and the hdPHQ-9. Investigators anticipate that the hdPHQ-9 will be a valid and responsive instrument that will isolate depressive symptoms in hemodialysis patients and ultimately improve the screening and diagnosis of depression. Investigators also expect that directly observed weekly fluoxetine treatment will be an effective way to manage depression among hemodialysis patients.

Conditions

Depression; Hemodialysis-Induced Symptom

Outcome Measures

Primary Outcomes (1)

• To Determine the Impact of Directly Observed Weekly Fluoxetine Treatment on Remission of Depression Among Hemodialysis Patients.

  remission of depression, defined as a week 12 Patient Health Questionnaire 9 (PHQ-9) total score of \<5. The survey consists of 9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max. A TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS. Less than 5 is total remission of depressive symptoms.

  3 years

Study Arms (1)

Fluoxetine Group

EXPERIMENTAL

Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.

Drug: Fluoxetine

Interventions

Fluoxetine DRUG

Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.

Also known as: Prozac

Fluoxetine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently on hemodialysis at a CDC dialysis unit
• English speaking
• able to provide informed consent

You may not qualify if:

• on hemodialysis for less than 3 months
• comorbid psychotic, bipolar, substance use dependence, Alzheimer's or dementia
• Not eligible for Phase II (intervention) if currently on antidepressant medication

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (10)

• Cohen SD, Norris L, Acquaviva K, Peterson RA, Kimmel PL. Screening, diagnosis, and treatment of depression in patients with end-stage renal disease. Clin J Am Soc Nephrol. 2007 Nov;2(6):1332-42. doi: 10.2215/CJN.03951106. Epub 2007 Oct 17.

  PMID: 17942763 BACKGROUND

• Hedayati SS, Bosworth HB, Kuchibhatla M, Kimmel PL, Szczech LA. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int. 2006 May;69(9):1662-8. doi: 10.1038/sj.ki.5000308.

  PMID: 16598203 BACKGROUND

• Watnick S, Wang PL, Demadura T, Ganzini L. Validation of 2 depression screening tools in dialysis patients. Am J Kidney Dis. 2005 Nov;46(5):919-24. doi: 10.1053/j.ajkd.2005.08.006.

  PMID: 16253733 BACKGROUND

• Cohen SD, Kimmel PL. Nutritional status, psychological issues and survival in hemodialysis patients. Contrib Nephrol. 2007;155:1-17. doi: 10.1159/000100952.

  PMID: 17369709 BACKGROUND

• Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int. 2000 May;57(5):2093-8. doi: 10.1046/j.1523-1755.2000.00059.x.

  PMID: 10792629 BACKGROUND

• Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Boyle DH, Verme D, Umana WO, Veis JH, Alleyne S, Cruz I. Behavioral compliance with dialysis prescription in hemodialysis patients. J Am Soc Nephrol. 1995 Apr;5(10):1826-34. doi: 10.1681/ASN.V5101826.

  PMID: 7787151 BACKGROUND

• Lacson E Jr, Bruce L, Li NC, Mooney A, Maddux FW. Depressive affect and hospitalization risk in incident hemodialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1713-9. doi: 10.2215/CJN.01340214. Epub 2014 Oct 2.

  PMID: 25278546 BACKGROUND

• Lopes AA, Albert JM, Young EW, Satayathum S, Pisoni RL, Andreucci VE, Mapes DL, Mason NA, Fukuhara S, Wikstrom B, Saito A, Port FK. Screening for depression in hemodialysis patients: associations with diagnosis, treatment, and outcomes in the DOPPS. Kidney Int. 2004 Nov;66(5):2047-53. doi: 10.1111/j.1523-1755.2004.00977.x.

  PMID: 15496178 BACKGROUND

• Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009 Jun;4(6):1089-96. doi: 10.2215/CJN.00290109. Epub 2009 May 7.

  PMID: 19423571 BACKGROUND

• Kauffman KM, Dolata J, Figueroa M, Gunzler D, Huml A, Pencak J, Sajatovic M, Sehgal AR. Directly Observed Weekly Fluoxetine for Major Depressive Disorder Among Hemodialysis Patients: A Single-Arm Feasibility Trial. Kidney Med. 2022 Jan 17;4(3):100413. doi: 10.1016/j.xkme.2022.100413. eCollection 2022 Mar.

  PMID: 35386606 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

The study sample size is small for multiple reasons, including more patients than anticipated scoring below the threshold on the PHQ-9 or already being on psychiatric medications before enrollment. conditions. There was no comparison group. As a result, we are unable to compare efficacy and safety with other treatments or to evaluate the potentially confounding effect of frequent interactions with the psychiatric nurse practitioner.

Results Point of Contact

• Title: Dr. Ashwini Sehgal
• Organization: MetroHealth System

axs81@case.edu

216-778-8484

Study Officials

• Ash Seghal, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The cross-sectional study will involve assessments of depressive symptoms (PHQ-9) and quality of life for 1083 patients. These data will be used to address Aim A. The single arm trial will involve 96 patients with DSM5-confirmed depression.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: January 5, 2018
• Study Start: March 1, 2018
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)