Medication-assisted Psychotherapy: Using Ketamine-enhanced Radically Open Dialectical Behavior Therapy (RO DBT) to Target Neural and Behavioral Mechanisms of Action in Adults With Moderate to Severe Depression
This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.
NCT06138691 — Treatment Resistant Depression
Status: Recruiting
http://inclinicaltrials.com/treatment-resistant-depression/NCT06138691/
Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression. The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days). Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.
NCT06138678 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT06138678/
A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy of ENA-001 in Preventing Postoperative Respiratory Depression
This study is a Phase II, randomized, placebo-controlled, double-blind trial in 200 subjects having general anesthesia for major elective surgery with postoperative pain management to evaluate the efficacy, safety and tolerability of ENA-001 as a therapy to prevent post operative respiratory depression.
NCT06137638 — Respiratory Depression
Status: Not yet recruiting
http://inclinicaltrials.com/respiratory-depression/NCT06137638/
The Role of Inflammation in Cognitive Dysfunction in Acute Depression as Determined by Experimental Inhibition of Tumor Necrosis Factor-alpha Signaling in a Randomized Controlled Trial.
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
NCT06136546 — Inflammation
Status: Not yet recruiting
http://inclinicaltrials.com/inflammation/NCT06136546/
The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression: A Randomized Controlled Study
The research to be conducted within the scope of the project will be randomized controlled, and the population of the research will be primiparous pregnant women reached through social media. Primiparous pregnant women in the 32nd - 40th weeks of pregnancy will be included in the study, and the sample size is determined by using the G*Power (3.1.9.2) program, considering a margin of error of 0.05 and data loss, with a power of 95% and a medium effect size; 27 people should be included in the experimental (baby massage) group and 27 people in the control group. In determining the groups, participants will be assigned to experimental and control groups using the "Randomizer.org" program. Pregnant women included in the research will be informed about the study and will be presented with an "Informed Consent Form" and "Voluntary Consent Form". Baby massage training will be given to the experimental group, and a reminder training will be given 2 weeks later. "Personal Information Form", "Prenatal Attachment Inventory" and "Beck Depression Inventory" will be applied to both groups at the beginning of the study, and postpartum 30-42 weeks. and 60-72. "Maternal Attachment Scale" and "Edinburg Postpartum Depression Scale" will be administered between days.
NCT06136520 — Postpartum Depression
Status: Completed
http://inclinicaltrials.com/postpartum-depression/NCT06136520/
Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression
Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.
NCT06132581 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT06132581/
Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.
NCT06132178 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT06132178/
Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
The goal of this clinical trial is to compare the effect of three level interventions(universal prevention, selective prevention and targeted prevention) in elderly depression and find out the most efficient intervention path. The main questions it aims to answer are: - Whether the pre-disease three-level prevention model (universal prevention, selective prevention and targeted prevention) is applicable for elderly depression in urban communities; - Which level of intervention has the best effect on elderly depression. Participants will be given the following treatments: - Level 1 intervention(universal prevention): Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors. - Level 2 intervention(selective prevention): Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms. - Level 3 intervention(targeted prevention): Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms. Researchers will compare control group to see if the three levels of intervention have a significant effect.
NCT06132061 — Depression in Old Age
Status: Not yet recruiting
http://inclinicaltrials.com/depression-in-old-age/NCT06132061/
The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN)
Patients belonging to Group 1 (Major Depression) and 2 (Bipolar Disorder) will be tested with psychometric and functional scales at baseline (T0) and after 4 weeks of pharmacological therapy (T1), to evaluate clinical and functional response to treatment. MDD patients will be screened for the lifetime and recent occurrence of clinically meaningful suicidal ideation and behavior prior to recruitment (-T1). Moreover, in the MDD group, the emergence of clinically meaningful suicidal ideation and behavior will be evaluated at the baseline (T0) and after 4 weeks (T1) by means of the C-SSRS, accordingly to the routine clinical practice. Furtherly, to accomplish the pursues of this research, the two groups will undergo neuroimaging evaluation and a blood collection at the two timepoints for measuring the expression of ncRNA before and after treatment. Meanwhile, a lumbar puncture (LP) for CSF collection will be carried out at the baseline, measuring central levels of Negr-1 and other biomarkers of neurotropism potentially related to the aforementioned role of Negr1 in MDD. Group 3 will be comprehensive of 10 subjects without current or previous diagnosis of psychiatric disorders (healthy controls), who will be evaluated at baseline with psychometric and functional scales, neuroimaging and blood samples collection for ncRNA. Data obtained by the multimodal assessment of HCs at the baseline will be employed as normalization features in the statistical analysis of patients' data.
NCT06131268 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT06131268/
("The Role of the Glutamatergic Neurotransmission in Post- Partum Depression: an Integrated Molecular-pharmaco-imaging Study")
Post-partum depression (PPD) is a prevalent subtype of major depressive disorder that causes a significant distress to the woman and substantial impact on the whole family. Many studies implicate the glutamatergic system in pathological processes relevant to PPD disorders. There is evidence that cell adhesion molecules (CAMs) play a key role in how glutamatergic circuits wire up during development and how glutamatergic synapses, once formed, operate. However, it is unclear how dysregulation in diverse CAMs alter glutamatergic circuitries responsible for emotional and social behavior. Here, the investigators propose to evaluate the molecular and neurobiological underpinnings of PPD focusing on CAMs at glutamatergic synapses by using an integrated approach from mouse models to human patients. Moreover, the investigators will also perform a pilot study to investigate the impact of selective antidepressants, known to be linked to CAMs, in both human and mice.
NCT06131255 — Post-partum Depression
Status: Not yet recruiting
http://inclinicaltrials.com/post-partum-depression/NCT06131255/