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Malek Bajbouj

6 papers in the library · 907 citations · publishing 2011-2026

Papers

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study

American Journal of Psychiatry May 21, 2019 Vanina Popova, Ella J. Daly, Madhukar Trivedi et al. 879 citations

Switching to esketamine nasal spray plus a new antidepressant led to a significantly greater reduction in depression severity after 28 days than switching to a new antidepressant alone in adults with treatment-resistant depression. The average improvement on the Montgomery-Åsberg Depression Rating Scale was 4 points greater with esketamine (95% CI -7.31 to -0.64). Earlier improvements were also seen. Common side effects included dissociation, nausea, vertigo, dysgeusia, and dizziness, which typically appeared shortly after dosing and resolved within 1.5 hours. Seven percent of esketamine patients discontinued due to adverse events versus 0.9% in the comparator group. The findings support esketamine as a rapidly acting option for this difficult-to-treat population.

Predicting Antidepressant Effects of Ketamine: the Role of the Pregenual Anterior Cingulate Cortex as a Multimodal Neuroimaging Biomarker

The International Journal of Neuropsychopharmacology August 10, 2022 Anne Weigand, Matti Gärtner, Milan Scheidegger et al. 22 citations

Activity in the pregenual anterior cingulate cortex (pgACC) during emotional stimulation can predict how well a single intravenous infusion of ketamine will relieve depression symptoms in people with major depressive disorder. In 24 patients, pgACC activity was linked to an increase in glutamate in the same brain region 24 hours after the infusion, and this glutamate increase was associated with greater symptom improvement. The findings suggest pgACC activity may serve as a neuroimaging biomarker for early treatment response to ketamine.

GH001 vs Placebo in Patients With Treatment-Resistant Depression

JAMA Psychiatry March 25, 2026 Wiesław Jerzy Cubała, Malek Bajbouj, Michael Bauer et al. 3 citations

A single day of treatment with an inhaled synthetic formulation of mebufotenin (GH001) significantly reduced depression symptoms in adults with treatment-resistant depression compared to placebo. In a randomized, double-blind trial of 81 patients, those receiving up to three escalating doses of GH001 showed an average 15.5-point greater improvement on the Montgomery-Åsberg Depression Rating Scale by day 8 than those on placebo. Remission rates were 57.5% for GH001 and 0% for placebo. No severe or serious adverse events occurred. The findings suggest GH001 may be a rapid-acting, well-tolerated treatment option for treatment-resistant depression.

Yoga-Based Group Intervention for Inpatients with Schizophrenia Spectrum Disorders-Feasibility, Acceptability, and Preliminary Outcomes of a Rater-Blinded Randomized Controlled Trial.

Schizophrenia bulletin November 16, 2024 Inge Hahne, Marco Zierhut, Niklas Bergmann et al. 3 citations

A yoga-based group intervention (YoGI) added to treatment-as-usual is feasible and acceptable for inpatients with schizophrenia spectrum disorders (SSD). In a randomized controlled trial with 50 inpatients, YoGI plus treatment-as-usual showed 95% protocol adherence, 91-94% retention, and a 6% dropout rate. Compared to treatment-as-usual alone, the yoga group had significant improvements in positive symptoms, depression, cognitive fusion, and a mindfulness subscale. Medium-to-large improvements were also seen in body mindfulness, negative and general symptoms, anxiety, stress, quality of life, and attention. No severe adverse events occurred. The findings suggest YoGI may provide benefits beyond standard care, but further robust trials are needed.

The Combination of Oxytocin with Mindfulness-Based Group Therapy Reduces Negative Symptoms in Schizophrenia Spectrum Disorders: A Triple-Blind, Placebo-Controlled, Randomized, Controlled Clinical Pilot Trial (OXYMIND)

medRxiv July 4, 2026 Marco Zierhut, Max Alt, Inge Maria Hahne et al.

Combining intranasal oxytocin with mindfulness-based group therapy may improve negative symptoms in schizophrenia spectrum disorders. In a pilot study, 47 participants received either oxytocin or placebo before four therapy sessions. Only the oxytocin group showed significant reductions in negative symptoms from baseline to post-intervention and at a 4-week follow-up, with small between-group effects favoring oxytocin at follow-up. No serious adverse events occurred. The findings support further large-scale trials.

Emotionalcognitive processing and brain metabolism after pharmacological challenge with ketamine

Pharmacopsychiatry September 1, 2011 Simone Grimm, Milan Scheidegger, A Henning et al.

Ketamine, a glutamatergic NMDA receptor antagonist with rapid antidepressant properties, was used to investigate the neurobiology of major depressive disorder. In a multimodal imaging study of 23 healthy subjects, a single ketamine infusion increased negative BOLD responses in brain regions involved in emotional processing, particularly limbic areas linked to emotional information and higher-order mental functions. During cognitive processing, ketamine affected negative BOLD responses in anterior but not posterior regions of the default-mode network. Strong correlations were found between glutamate, glutamine, GABA, and glutamine/glutamate ratios and these brain responses after ketamine administration, suggesting a link to glutamatergic neurotransmission.