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Schizophrenia clinical trials

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NCT ID: NCT02304432 Completed - Schizophrenia Clinical Trials

Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine

DCS
Start date: September 27, 2015
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the glycine decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm of treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled exposures to DCS or placebo. The length of each double-blind arm is limited to six weeks to minimize the length of symptom exacerbation experienced by the subjects when they are receiving placebo. The randomization scheme will allow two consecutive exposures to DCS, but will not allow two consecutive exposures to placebo, again to minimize the length of any symptom exacerbation. At the end of the open-label DCS trial, the following procedures will be carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory evoked potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a DCS will be assessed. Baseline data on all of these measures were previously obtained as part of a different study registered in clinical trials.gov - NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo will be compounded and dispensed by the McLean Hospital Pharmacy. The investigators hypothesize that mutation carriers will have reduced endogenous brain glycine and GABA levels and increased brain glutamate and glutamine levels. DCS administration will increase brain glycine in the two carriers compared to baseline and treatment with glycine (0.8g/kg). The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs modulated by NMDA in mutation carriers compared with non-carrier family members and controls. . The investigators hypothesize that DCS, but not placebo, will improve positive, negative and affective symptoms as well as neurocognitive function. The investigators also hypothesize that DCS will improve clinical and cognitive functioning, will partially normalize decreased baseline glycine and GABA and increased glutamate and glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked potentials.

NCT ID: NCT02302209 Completed - Schizophrenia Clinical Trials

Dyad Oxytocin Study (DOS)

DOS
Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.

NCT ID: NCT02298985 Completed - Clinical trials for Chronic Schizophrenia

Curcumin Addition to Antipsychotic Treatment in Chronic Schizophrenia Patients

Start date: January 2015
Phase: Phase 4
Study type: Interventional

Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of these patients has remained a persistent public health problem since medication-resistant patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic schizophrenia patients.

NCT ID: NCT02288845 Completed - Schizophrenia Clinical Trials

Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.

NCT ID: NCT02287584 Completed - Schizophrenia Clinical Trials

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

NCT ID: NCT02283437 Completed - Family Caregivers Clinical Trials

A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia

PSBPF
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBPF) for Chinese family caregivers in schizophrenia spectrum disorders. A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups (PSBPF and behavioral management group) and routine outpatient service (control group) for 150 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 18-month follow-up.

NCT ID: NCT02282761 Completed - Schizophrenia Clinical Trials

A Trial to Assess the Antipsychotic Efficacy of ITI-007

Start date: November 2014
Phase: Phase 3
Study type: Interventional

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

NCT ID: NCT02281773 Completed - Schizophrenia Clinical Trials

A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.

Start date: November 10, 2014
Phase: Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

NCT ID: NCT02281162 Completed - Schizophrenia Clinical Trials

The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain

Start date: November 2014
Phase: N/A
Study type: Observational

Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.

NCT ID: NCT02267070 Completed - Schizophrenia Clinical Trials

Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

CT&E
Start date: November 2013
Phase: N/A
Study type: Interventional

This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.