Poststroke Depression in Hemorrhagic Stroke

• ClinicalTrials.gov Identifier: NCT03826875
• Recruitment Status: Recruiting
• First Posted: February 1, 2019
• Last Update Posted: November 13, 2020
• Sponsor: University of Washington
• Information provided by (Responsible Party): Michael Robert Levitt, MD, University of Washington

Study Description

Brief Summary:

A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Condition or disease	Intervention/treatment	Phase
Stroke Hemorrhagic; Depression	Drug: Fluoxetine; Drug: Placebo	Early Phase 1

Detailed Description:

Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blinded placebo-controlled randomized trial
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: February 25, 2024
• Estimated Study Completion Date: November 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.	Drug: Fluoxetine; Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life; Other Name: Prozac
Placebo Comparator: Placebo; Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.	Drug: Placebo; Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life

Outcome Measures

Primary Outcome Measures :

1. Depression [ Time Frame: 1 year ]
   Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 21 item questionnaire to treat and diagnosis severe depression. Examining a different symptom or aspect of depression such as mood, guilty feelings, suicidal ideation, etc.. The first 17 questions are used for scoring. A total score is tallied from 1-17 and if the score totals: 0-7 normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression, >23 very severe depression.
2. Depression [ Time Frame: 1 year ]
   Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire to treat and diagnose depression where score totals of: 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.

Secondary Outcome Measures :

1. Anxiety [ Time Frame: 1 year ]
   Anxiety will be assessed using the Hamilton Rating Scale for Anxiety. The Hamilton Anxiety Rating Scale measures the severity of anxiety through looking at both psychic and somatic anxiety. Each item is scored on a scale of 0 to 4, with a total range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
2. Fatigue [ Time Frame: 1 year ]
   Fatigue will be assessed using the Fatigue Severity Scale. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients exhibiting depression. The scale is designed to differentiate fatigue from clinical depression since they share similar symptoms. Scoring is done by calculating the average response to the question and people with depression typically score about 4.5 whereas those with fatigue average about 6.5.
3. Healthcare Utilization [ Time Frame: 1 year ]
   Healthcare Utilization will be assessed using the Self-Report Health Service Utilization and Medication Use. The Self-Report Health Service Utilization and Medication Use scale measures the frequency and purpose of healthcare utilization to include hospitalization, mental health care, inpatient admissions, outpatient visits, emergency room visits, skilled nursing facility/rehabilitation center visits, and medication usage. Scoring is the number of utilization per category per period.
4. Social Support [ Time Frame: 1 year ]
   Social Support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a scale to determine a patient's social support system from Family, Friends, and significant other. The scale is comprised of a total of 12 items with 4 items for each subscale. Scoring: Total scale average will be taken whereas for each subscale the average will be taken as: Significant other average responses from questions 1,2,5,10; Family average responses from questions 3,4,8,11; friends average responses from questions 6,7,9,12. Mean scale score ranging from 1-2.9 is considered low support; a score of 3-5 is considered moderate support; a score from 5.1. to 7 is considered high support.
5. Sleep Disturbance [ Time Frame: 1 year ]
   Sleep Disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System-Sleep Disturbance scale (PROMIS-Sleep Disturbance). PROMIS is a sleep disturbance scale used to assess pure domain of sleep disturbance. Short form is scored based on using a data collection tool that automatically calculates scores and will be using responses to each item for each participant. Scoring: Total raw score for a measure will be converted according to PROMIS Score Conversion table and it will translate the total raw score into a T-score for each participant. The T-score rescales the raw into a standardized score with a mean of 50 and a standard deviant of 10. Therefore, a person with a T-score of 40 is one standard deviation below the mean. A higher PROMIS T-score represents more of the concept being measured.
6. Function [ Time Frame: 1 year ]
   Function will be assessed using the The Short Form (18) Health Survey (SF-18). The SF-18is a 18-item questionnaire to assess health-related quality-of-life. Health concepts of physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scoring: RAND scoring is composed of precoded numeric values that are recoded per RAND scoring key and each item is scored on a 0-100 range so that the lowest and highest possible scores are 0 and 100. Scores represent the percentage of total possible score achieved. In the second part of the scoring key, items are averaged together to create each scale allowing the scale to represent the average for all items in the scale that was answered.
7. Function [ Time Frame: 1 year ]
   Function will be assessed using the Barthel Index. The Barthel Index is a scale used to determine functional status, measuring performance in activities of daily living. Values assigned to each item are based on a time and amount of actual assistance required if a patient is unable to perform the activity. Also is able to be used to understand the course of rehabilitation and show how much progress toward independence as occurred. If there is a lack of improvement in the Barthel Index after a reasonable period of treatment it indicates poor potential for rehab. Scoring: A patient scoring 100 is continent and able to do daily tasks by themselves. Total score is not as significant or meaningful as the breakdown into individual items but rather indicate where deficiencies are.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Patients 18-85 years of age aged 18 years and older will be included.

Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included.

Only patients who provide informed consent will be included.

Exclusion Criteria:

Non-English speaking patients will be excluded.

Patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded.

Patients with medical contraindications to fluoxetine therapy will be excluded.

Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded.

Patients with active psychosis will be excluded.

Patients who are incarcerated or in police custody will be excluded.

Patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered Montreal Cognitive Assessment; Patients scoring >26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.

Contacts and Locations

Contacts

Contact: Cory M Kelly; 206-685-3043; kellycm@neurosurgery.washington.edu

Locations

United States, Washington

Harborview Medical Center; Recruiting

Seattle, Washington, United States, 98104

Contact: Cory Kelly, BS 206-685-3043

Sponsors and Collaborators

University of Washington

Investigators

• Principal Investigator: Michael Levitt, MD; University of Washington

More Information

• Responsible Party: Michael Robert Levitt, MD, Assistant Professor, School of Medicine, Neurological Surgery, University of Washington
• ClinicalTrials.gov Identifier: NCT03826875
• Other Study ID Numbers: STUDY00002718
• First Posted: February 1, 2019
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No individual participant data provided.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael Robert Levitt, MD, University of Washington:

stroke; hemorrhagic stroke; subarachnoid hemorrhage; depression

Additional relevant MeSH terms:

Stroke; Subarachnoid Hemorrhage; Hemorrhagic Stroke; Depression; Depressive Disorder; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Mood Disorders; Mental Disorders; Hemorrhage; Pathologic Processes; Intracranial Hemorrhages; Fluoxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors