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Depression, Bipolar clinical trials

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NCT ID: NCT04640636 Active, not recruiting - Suicidal Ideation Clinical Trials

IM Ketamine vs Midazolam for Suicidal ER Patients

Start date: January 2, 2021
Phase: Phase 4
Study type: Interventional

Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.

NCT ID: NCT04469322 Completed - Depression Clinical Trials

Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression

Start date: September 30, 2014
Phase: N/A
Study type: Interventional

Many patients with depression do not respond well to medication and are diagnosed with treatment refractory depression (TRD). Sometimes medications don't work because an individual metabolizes the drugs in an atypical manner (too fast/slow). Alternatively, drugs may fail to work because the underlying sub-type of depression is not effectively targeted by a medication. This study will use genetic testing of subjects with TRD to personalize the drug treatment of depression and guide the patient to a better clinical outcome. In the guided group, the clinician will receive a pharmacogenetic report to help individually tailor medication selection for TRD patients, potentially allowing the clinician to pick more effective medications right away, and when necessary, use drug combinations that are well-tolerated and less likely to cause unwanted side effects. The control group will receive a sham genetic report and be treated according to typical standards of care. The investigators will conduct our study in a "real world" setting, with few restrictions on which TRD patients can participate. In this way, the findings may be more likely to reveal how useful genetic testing will be when applied more broadly in psychiatry.

NCT ID: NCT04399070 Not yet recruiting - Clinical trials for Major Depressive Disorder

The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

ECT
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.

NCT ID: NCT04121091 Completed - Anhedonia Clinical Trials

Pramipexole to Target "Anhedonic Depression"

PILOT-PRAXOL
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.

NCT ID: NCT04057378 Recruiting - Clinical trials for Depressive Disorder, Major

Optimal Electrical Stimulus During Electroconvulsive Therapy

Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

Synopsis Aim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli. Design: National, register-based randomized trial, unmasked with two treatment arms. Primary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (< 11 on the MADRS-S) than a 0.5ms pulse width stimulus. Secondary objectives include testing for differences in: self-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm. Inclusion criteria: At least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10. An indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent. Exclusion criteria: If the investigator judges a certain pulse width to be inappropriate for the patient. Inclusion time 2019-05-01-2022-11-15. Abbreviations 1. CGI: Clinical Global Impression Scale 2. CPRS: The Comprehensive Psychopathological Rating Scale 3. ECT: Electroconvulsive therapy 4. EQ5D: EuroQual-group 5 Dimensions Scale 5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision, 6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version. 7. Q-ECT: Swedish national quality register for ECT 8. VAS: Visual analogue scale

NCT ID: NCT03538275 Completed - Healthy Clinical Trials

Chronobiology and Depression: Circadian Analytics as a Biomarker for Depressive Subtypes

Start date: March 13, 2018
Phase:
Study type: Observational

An objective measure of treatment response could be a valuable new tool in the armamentarium of depression management, and this holds true for stimulation-based and pharmacological therapies alike. Hence, the Medibio Depression Monitoring Study will use the Medibio analytics platform to characterize autonomic, circadian, and sleep patterns before and during the initial 8 weeks of pharmacologic therapy for moderate-to-severe depression. The study will also explore any differences in these measures between treatment responders and non-responders, and between depression subtypes, including bipolar and unipolar depression. The study will also characterize longitudinal, ambulatory EEG measures throughout the observation period.

NCT ID: NCT03423680 Recruiting - Depression, Bipolar Clinical Trials

A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

APOLLO
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features. This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.

NCT ID: NCT03360942 Active, not recruiting - Clinical trials for Treatment Resistant Depression

Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression

Start date: April 18, 2016
Phase:
Study type: Observational

The long term follow up of a pilot study in which the invesitagors proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

NCT ID: NCT03287037 Completed - Clinical trials for Depressive Disorder, Major

The Effects of tDCS on Depressive Symptoms,Neurocognitive Function and HRV in Unipolar Depression and Bipolar Depression

Start date: October 2016
Phase: N/A
Study type: Interventional

The study aimed to investigate whether transcranial direct current stimulation could improve depressive symptoms, neurocognitive function and modulate heart rate variability in unipolar and bipolar depression.

NCT ID: NCT02919280 Recruiting - Depression Clinical Trials

Dallas 2K: A Natural History Study of Depression

D2K
Start date: September 2016
Phase:
Study type: Observational

The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of 2,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological and neurobiological factors that contribute to anti-depressant treatment response: remission, recurrence, relapse and individual outcomes in depressive disorders. Hence, the expected duration of this study is 20 years in length. Since this is an observational study, investigators will explore a comprehensive panel of carefully selected participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (structural, functional brain circuitry) with the goal to develop the most robust predictive models of treatment response and of depression outcomes. There is no medication or non-medication treatment or intervention provided by this study. Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive disorder and will be currently receiving or will be prescribed standard of care medication or non-medication based treatments by their providers/clinicians. The study cohort will reflect the wide range of patients seen in typical primary or psychiatric care settings, and may include unipolar or bipolar disorders and dysthymia (a more chronic form of depression). The cohort will be broadly representative of and generalizable to the US general population as a whole.