Poststroke Depression in Hemorrhagic Stroke

NCT03826875 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00002718
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Hemorrhagic; Depression

Keywords

stroke; hemorrhagic stroke; subarachnoid hemorrhage; depression

Outcome Measures

Primary Outcomes (2)

• Depression

  Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 21-item questionnaire to treat and diagnose severe depression. Examining a different symptom or aspect of depression, such as mood, guilt feelings, or suicidal ideation. The first 17 questions are used for scoring. The first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression.

  1 year

• Depression

  Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire to treat and diagnose depression. The minimum score is 1, and the maximum score is 27. 1-4: minimal depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression

  1 year

Secondary Outcomes (7)

• Anxiety

  1 year

• Fatigue

  1 year

• Healthcare Utilization

  1 year

• Social Support

  1 year

• Sleep Disturbance

  1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.

Drug: Placebo

Interventions

Fluoxetine DRUG

Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life

Also known as: Prozac

Treatment

Placebo DRUG

Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Hemorrhagic Stroke; Depression; Stroke; Subarachnoid Hemorrhage

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

The number of participants enrolled was too low to draw a statistically significant result. Used 6-month follow-up data, as many participants did not complete the 12-month follow-up assessment.

Results Point of Contact

• Title: Professor of Neurological Surgery
• Organization: University of Washington

mlevitt@uw.edu

2067449330

Study Officials

• Michael Levitt, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine, Neurological Surgery

Model Details: double-blinded placebo-controlled randomized trial

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: March 1, 2019
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)