Post-stroke Depression

15

Review clinical trials related to Post-stroke Depression. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors

The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).

Participants needed: 350
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center, HoustonUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stro... [+5]

Stroke event unrelated to vascular risk factors (e.g., drug use) or transient is... [+8]

Status: Recruiting

Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression

The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.

Participants needed: 142
Trial details
Age: 50-85Biological sex: AllType: InterventionalSponsor: Assaf-Harofeh Medical CenterUpdated: Apr 17, 2026Locations: 1
Eligibility criteria

Age between 50 -85 [+5]

Inability to attend scheduled clinic visits and/or comply with the study protoco... [+17]

Status: Not yet recruiting

Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression

This study investigates whether combining virtual reality mindfulness-based cognitive therapy (VR-MBCT) with transcranial direct current stimulation (tDCS) can effectively treat depression occurring after a stroke (post-stroke depression, PSD). The goal is to determine if this combined approach is more beneficial than either treatment alone or standard care in alleviating depressive symptoms. The study will enroll adults aged 18-65 who have experienced a stroke within the past week, are medically stable, and exhibit moderate to severe depression symptoms. Participants must be right-handed and able to undergo MRI scans and study assessments. Individuals with certain neurological or psychiatric conditions, other major health issues, or specific contraindications for tDCS will not be eligible. Procedures: This is a randomized controlled trial lasting approximately 28 weeks, divided into two phases. In the first phase (8 weeks), participants are randomly assigned to one of four groups: Group 1: Receives sham (placebo) versions of both VR-MBCT and tDCS plus standard medication. Group 2: Receives active tDCS and sham VR-MBCT plus standard medication. Group 3: Receives active VR-MBCT and sham tDCS plus standard medication. Group 4: Receives both active VR-MBCT and active tDCS plus standard medication. Treatments are administered 5-6 times per week for 4 weeks, followed by a 4-week blinded follow-up.The primary outcome is the change in depression scores (HDRS-24、PHQ-9) from baseline to 8 weeks. Secondary outcomes include rates of clinical response, remission, relapse, treatment acceptability, and changes in anxiety, sleep quality, and daily functioning.

Participants needed: 120
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Feb 20, 2026
Eligibility criteria

Aged 18 to 65 years (inclusive). [+9]

History of treatment-resistant depression, defined as failure to respond to at l... [+13]

Status: Recruiting

Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke

Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional medical expenses and care pressure to families. Society also needs to bear higher medical costs. Currently, the early diagnosis of PSD is difficult, which may lead to poor prognosis after stroke. This study aims to utilize machine learning technology to integrate multi-dimensional indicators of patients with ischemic stroke, establish a risk prediction model for PSD, and assist in early, accurate, and individualized assessment of PSD risk in clinical practice.

Participants needed: 488
Trial details
Biological sex: AllType: ObservationalSponsor: Min SuUpdated: Feb 5, 2026Locations: 1
Eligibility criteria

Patients with acute ischemic stroke; [+2]

Confusion of consciousness,severe cognitive impairment, etc [+2]

Status: Not yet recruiting

Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke

Stroke is a major cause of long-term disability and is often associated with reduced quality of life, depression, anxiety, and fatigue. Rehabilitation plays a key role in recovery, and robotic-assisted gait training provides intensive, repetitive, and individualized therapy. However, its effects on psychological outcomes and quality of life are not fully established. This randomized controlled trial will compare conventional rehabilitation combined with robotic-assisted gait training to conventional rehabilitation combined with treadmill training in stroke survivors. Both groups will receive treatment 5 days per week for 6 weeks. Assessments will be conducted at baseline, after 6 weeks of treatment, and at 3 months after treatment. The primary outcome is quality of life. Secondary outcomes include depression, anxiety, and fatigue. The results of this study will provide new evidence on the benefits of robotic rehabilitation for improving both physical and psychological well-being after stroke.

Participants needed: 36
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Meltem Gunes AkinciUpdated: Jan 26, 2026
Eligibility criteria

Age between 18 and 75 years [+3]

Severe cognitive or communication impairment [+8]

Status: Recruiting

Allopregnanolone (Zuranolone) in Post-stroke Depression

The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Participants needed: 6
Trial details
Phase: Phase 2Age: 21-65Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

21-65 years old of any sex and race/ethnicity [+2]

Have abused or been dependent on narcotics, recreational drug use, or alcohol [+7]

Status: Not yet recruiting

A Study on the Application of Positive Psychological Counseling Based on "Dou Bao" Software in Patients With Post-stroke Depression

Patients with PSD have the characteristics of high incidence rate, difficult identification and great harm. However, the existing AI chat platforms have not developed any relevant software or programs for PSD patients. Given that the chatbot function in the "Douba" software is relatively mature and can flexibly modify the corresponding intelligent agent according to user needs, this study intends to appropriately supplement and optimize the AI agent in the "Douba" software to explore the effect of the chatbot in the software in alleviating the symptoms of PSD patients.

Participants needed: 240
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineUpdated: Jan 13, 2026
Eligibility criteria

Meets the criteria of either the "Chinese Guidelines for the Diagnosis and Treat... [+5]

Those with severe functional impairments of important organs such as the heart,... [+1]

Status: Not yet recruiting

Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke

This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place. The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke. To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed. Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls. Independent Variables: Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs. Health education: received vs. not received. Dependent Variables: Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale). Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Santiago de CompostelaUpdated: Jan 15, 2026
Eligibility criteria

Anterior or posterior cerebral occlusion

Intracranial hemorrhage [+3]

Status: Recruiting

Physical Capacity Building for Chronic Stroke

Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. Investigators believe that individuals who have had a stroke need to be treated similarly. Investigators will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.

Participants needed: 76
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Medical University of South CarolinaUpdated: Dec 8, 2025Locations: 1
Eligibility criteria

Age 18-80 [+7]

Unable to ambulate at least 150 feet or experienced intermittent claudication wh... [+13]

Status: Recruiting

The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.

Background: Light is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization. Depression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role. The hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes. Method: Stroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting. Examination: Validated tests for fatigue, depression, sleep and cognitive functions. Pathophysiological studies: * MRI focusing on cerebral blood flow, metabolism, and cerebral networks. * Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness/arousal and depression. * Sleep assessments.

Participants needed: 45
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Rigshospitalet, DenmarkUpdated: Apr 15, 2025Locations: 1
Eligibility criteria

Patients scoring moderate-severe fatigue and/or depression OR NO fatigue and/or...

GCS < 15 [+7]

Status: Not yet recruiting

Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression

Post-stroke depression (PSD) is characterized primarily by low mood and loss of interest following a stroke. It is one of the most common and serious complications of stroke, with an incidence of 11% to 41% within two years post-stroke. PSD significantly impacts stroke prognosis, not only hindering neurological recovery but also increasing clinical disability and mortality rates, thereby imposing substantial economic and psychological burdens on families and society. Therefore, preventing PSD is crucial for stroke rehabilitation. Clinical trials have demonstrated that preventive antidepressant treatment can reduce PSD incidence and improve clinical outcomes; however, controversies remain regarding the timing, methods, and safety. Meanwhile, preventive psychological therapy faces challenges in implementation due to effectiveness, accessibility, and cost-effectiveness. Remote ischemic preconditioning (RIC) is a non-invasive, cost-effective, and non-pharmacological intervention. By modulating small molecules in the peripheral and central nervous systems through transient, periodic limb blood flow restriction and reperfusion, RIC reverses neurobiological changes and demonstrates neuroprotective potential in various neurological diseases. Recently, a study showed that RIC is safe and effective in preventing PSD; however, the sample size is small and the specific mechanisms remain unclear. Therefore, this study aims to further explore the role and mechanisms of RIC in PSD prevention.

Participants needed: 240
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Xuanwu Hospital, BeijingUpdated: Apr 10, 2025Locations: 5
Eligibility criteria

Patient age≥18 years; [+6]

Baseline HAMD-24 scores ≥8; [+14]

Status: Not yet recruiting

Investigating How the RECT Impacts Brain Functional States Through the ACC-cerebellar Loop

Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. The study will be divided into 4 groups: the first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task, the second group will receive right cerebellar single-pulse TMS stimulation combined with the RECT task, the third group will receive midline cerebellar single-pulse TMS stimulation combined with the RECT task, and the fourth group will receive sham cerebellar single-pulse TMS stimulation combined with the RECT task. Divide the participants into groups of 15 people each, following a 1:1:1:1 ratio. Based on the above testing, the stimulus method that results in the most significant change in the midline of the frontal lobe will be identified. Experiment 2: Based on the research from Experiment 1, the most significant approach affecting theta neural oscillations in the medial frontal gyrus will be identified. This stimulation protocol will be combined with left dorsolateral prefrontal cortex iTBS stimulation in Experiment 2. The research aim of Experiment 2 is to investigate the most effective stimulation method for enhancing midline theta neural oscillations in the frontal lobe, in combination with left dorsolateral prefrontal cortex iTBS, for the treatment of post-stroke depression patients. This study will include 40 post-stroke depressed patients, and each participant must meet the inclusion criteria. The first group of participants, consisting of 20 individuals, will receive the optimal combination intervention. The second group of participants will only receive iTBS stimulation, without any additional intervention strategies used in Experiment 1. Patients will undergo Hamilton Depression Scale assessment and resting state and task state EEG collection at baseline, one week after intervention, and two weeks after intervention.The primary outcome will be the Hamilton Depression Scale, with EEG-related data being analyzed as a secondary outcome. Task-oriented EEG detection will include both facial expression recognition paradigm and oddball experiment paradigm. Reaction time, accuracy, and completion status will be recorded simultaneously in the experiment. The experiment will record patients' tolerance and any adverse events that occur.

Participants needed: 100
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: The Second Affiliated Hospital of Kunming Medical UniversityUpdated: Apr 4, 2025
Eligibility criteria

Onset of stroke <6 months ago, or >6 months since the last stroke event; [+7]

History of epilepsy or psychiatric disorders (including depression, anxiety, or... [+12]

Status: Not yet recruiting

The Research Team Aims to Elucidate the Impact of ITBS (intermittent Theta Burst Stimulation) on the HPA Axis and Post-stroke Negative Emotions/depression by Conducting Human Experiments That Target Various Brain Regions.

The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.

Participants needed: 60
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: The Second Affiliated Hospital of Kunming Medical UniversityUpdated: Mar 28, 2025
Eligibility criteria

Initial stroke onset <6 months, or the last stroke event occurred more than 6 mo... [+8]

History of epilepsy or psychiatric disorders (including depression, anxiety, or... [+12]

Status: Not yet recruiting

To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation

Experiment 1: Utilizing a transcranial magnetic stimulation-electroencephalography/functional near-infrared spectroscopy system, the investigators aim to determine whether transcranial magnetic stimulation of the cerebellum can alter neural oscillations and blood flow changes in the prefrontal cortex. The investigators will recruit 80 healthy volunteers and 80 stroke patients with middle cerebral artery infarction, each meeting the inclusion criteria. Twenty healthy volunteers and twenty patients will be randomly selected to receive a single-pulse transcranial magnetic stimulation (TMS) to the cerebellar vermis. The investigators will record cerebellar transcranial evoked potentials (TEP) in the EEG to assess cerebellar cortical excitability and inhibition and evaluate individuals using functional near-infrared spectroscopy to analyze changes in prefrontal blood flow and brain networks. The other 40 healthy volunteers and 40 patients will receive a single-pulse TMS to the right or left cerebellum, and similar assessments will be made. The remaining 20 healthy volunteers and 20 patients will receive a sham iTBS, with similar assessments. Experiment 2: Through a facial expression recognition task, this experiment aims to clarify the cerebellum's increased perception of negative emotions, thereby achieving a rebalance from "controlled" to "automatic" regulation of negative emotions, ultimately playing a role in "automatic" emotional adjustment. The 80 healthy volunteers from Experiment 1 will be equally divided into four groups based on stimulation site: the cerebellar vermis; the right cerebellum; the left cerebellum; the sham stimulation. Each group will perform the facial expression recognition task during the TMS stimulation. The investigators will collect functional near-infrared spectroscopy and task-based EEG data from the participants during stimulation while also recording their response times, accuracy rates, and completion conditions, including their tolerance of the experiment and any adverse events.

Participants needed: 160
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: The Second Affiliated Hospital of Kunming Medical UniversityUpdated: Mar 6, 2025
Eligibility criteria

Onset of stroke <6 months ago, or >6 months since the last stroke event; [+7]

History of epilepsy or psychiatric disorders (including depression, anxiety, or... [+12]

Status: Recruiting

Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are: * Does Auricular acupuncture reduce the time it took participants to fall asleep? * Dose Auricular acupuncture increase the number of hours participants slept? * Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)? * What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke. Participants will: * Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks. * Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks. * Keep a diary sleep of their symptoms and the number of times they use sleeping pills.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Medicine and Pharmacy at Ho Chi Minh CityUpdated: Oct 1, 2024Locations: 1
Eligibility criteria

Patients aged 18 years or older, with a post-stroke period of 03 months or more,... [+1]

Patients with insomnia before the stroke. [+5]