Poststroke Depression in Hemorrhagic Stroke

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT03826875

Collaborator

(none)

224

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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

Anticipated Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double-blinded placebo-controlled randomized trialdouble-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 :

Mar 1, 2019

Anticipated Primary Completion Date :

Feb 25, 2024

Anticipated Study Completion Date :

Nov 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 Names: 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

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 Names:

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

Depression [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.
Depression [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

Anxiety [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.
Fatigue [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.
Healthcare Utilization [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.
Social Support [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.
Sleep Disturbance [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.
Function [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.
Function [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

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.