zonisamide has been researched along with Weight Gain in 7 studies
Zonisamide: A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.
zonisamide : A 1,2-benzoxazole compound having a sulfamoylmethyl substituent at the 3-position.
Weight Gain: Increase in BODY WEIGHT over existing weight.
| Excerpt | Relevance | Reference |
|---|---|---|
| "In this 10-week, double blind randomized placebo controlled clinical trial, forty one patients with schizophrenia diagnosed according to DSM-IV-TR criteria who were taking a stable dose of atypical antipsychotic are allocated into one of the two groups of zonisamide or placebo group." | 9.17 | The effect of zonisamide on antipsychotic-associated weight gain in patients with schizophrenia: a randomized, double-blind, placebo-controlled clinical trial. ( Ghanizadeh, A; Nikseresht, MS; Sahraian, A, 2013) |
| "Outpatients with schizophrenia or schizoaffective disorder (DSM-IV-TR criteria) were randomly assigned to olanzapine alone (n = 50), olanzapine plus algorithm A (olanzapine + A [amantadine 200 mg/d with possible switches to metformin 1,000-1,500 mg/d and then to zonisamide 100-400 mg/d; n = 76]), or olanzapine plus algorithm B (olanzapine + B [metformin 1,000-1,500 mg/d with possible switches to amantadine 200 mg/d and then to zonisamide 100-400 mg/d; n = 73])." | 9.16 | Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. ( Case, M; Hoffmann, VP; Jacobson, JG, 2012) |
| "Weight gain is commonly observed with olanzapine treatment." | 9.16 | A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain. ( Guerdjikova, AI; Keck, PE; Martens, B; McCoy, J; McElroy, SL; Moeller, D; Mori, N; Winstanley, E, 2012) |
| "In this 10-week, double blind randomized placebo controlled clinical trial, forty one patients with schizophrenia diagnosed according to DSM-IV-TR criteria who were taking a stable dose of atypical antipsychotic are allocated into one of the two groups of zonisamide or placebo group." | 5.17 | The effect of zonisamide on antipsychotic-associated weight gain in patients with schizophrenia: a randomized, double-blind, placebo-controlled clinical trial. ( Ghanizadeh, A; Nikseresht, MS; Sahraian, A, 2013) |
| "Outpatients with schizophrenia or schizoaffective disorder (DSM-IV-TR criteria) were randomly assigned to olanzapine alone (n = 50), olanzapine plus algorithm A (olanzapine + A [amantadine 200 mg/d with possible switches to metformin 1,000-1,500 mg/d and then to zonisamide 100-400 mg/d; n = 76]), or olanzapine plus algorithm B (olanzapine + B [metformin 1,000-1,500 mg/d with possible switches to amantadine 200 mg/d and then to zonisamide 100-400 mg/d; n = 73])." | 5.16 | Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. ( Case, M; Hoffmann, VP; Jacobson, JG, 2012) |
| "Weight gain is commonly observed with olanzapine treatment." | 5.16 | A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain. ( Guerdjikova, AI; Keck, PE; Martens, B; McCoy, J; McElroy, SL; Moeller, D; Mori, N; Winstanley, E, 2012) |
| "Juvenile myoclonic epilepsy is a common idiopathic generalized epileptic syndrome that includes generalized myoclonic seizures and commonly generalized tonic-clonic and generalized absence seizures." | 2.45 | The first line of therapy in a girl with juvenile myoclonic epilepsy: should it be valproate or a new agent? ( Abou-Khalil, B; Montouris, G, 2009) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 2 (28.57) | 29.6817 |
| 2010's | 5 (71.43) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Ghanizadeh, A | 1 |
| Nikseresht, MS | 1 |
| Sahraian, A | 1 |
| Shin, JH | 1 |
| Gadde, KM | 2 |
| Østbye, T | 1 |
| Bray, GA | 1 |
| Montouris, G | 1 |
| Abou-Khalil, B | 1 |
| Hoffmann, VP | 1 |
| Case, M | 1 |
| Jacobson, JG | 1 |
| Lim, J | 1 |
| Ko, YH | 1 |
| Joe, SH | 1 |
| Han, C | 1 |
| Lee, MS | 1 |
| Yang, J | 1 |
| McElroy, SL | 1 |
| Winstanley, E | 1 |
| Mori, N | 1 |
| Martens, B | 1 |
| McCoy, J | 1 |
| Moeller, D | 1 |
| Guerdjikova, AI | 1 |
| Keck, PE | 1 |
| Wallingford, NM | 1 |
| Sinnayah, P | 1 |
| Bymaster, FP | 1 |
| Krishnan, RK | 1 |
| McKinney, AA | 1 |
| Landbloom, RP | 1 |
| Tollefson, GD | 1 |
| Cowley, MA | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Zonisamide for Weight Reduction in Obese Adults[NCT00275834] | 225 participants (Actual) | Interventional | 2006-01-31 | Completed | |||
| The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia[NCT00401973] | Phase 3 | 199 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| A Double-Blind, Placebo-Controlled Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain[NCT00363376] | Phase 3 | 42 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms. (NCT00275834)
Timeframe: 1 year
| Intervention | kg (Mean) |
|---|---|
| Placebo | -4.0 |
| Zonisamide 200 mg | -4.4 |
| Zonisamide 400 mg | -7.3 |
C reactive Protein (CRP) (NCT00275834)
Timeframe: 1 year
| Intervention | mg/L (Mean) |
|---|---|
| Placebo | 0.523 |
| Zonisamide 200 mg | 0.536 |
| Zonisamide 400 mg | 0.443 |
This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere. (NCT00275834)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|---|
| Placebo | 6 |
| Zonisamide 200 mg | 17 |
| Zonisamide 400 mg | 24 |
These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate. (NCT00275834)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|---|
| Placebo | 23 |
| Zonisamide 200 mg | 26 |
| Zonisamide 400 mg | 41 |
Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression. (NCT00275834)
Timeframe: 1 year
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | 2.12 |
| Zonisamide 200 mg | 2.76 |
| Zonisamide 400 mg | 1.95 |
Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect. (NCT00275834)
Timeframe: 1 year
| Intervention | cm (Mean) |
|---|---|
| Placebo | -4.8 |
| Zonisamide 200 mg | -6.1 |
| Zonisamide 400 mg | -8.5 |
(NCT00275834)
Timeframe: Baseline, 1 year
| Intervention | mm Hg (Least Squares Mean) | |
|---|---|---|
| Systolic | Diastolic | |
| Placebo | -0.6 | -1.5 |
| Zonisamide 200 mg | -4.4 | -3.6 |
| Zonisamide 400 mg | -1.9 | -3.9 |
(NCT00275834)
Timeframe: baseline, 1 year
| Intervention | mg/dL (Least Squares Mean) | |||
|---|---|---|---|---|
| Total Cholesterol | LDL Cholesterol | HDL Cholesterol | Triglycerides | |
| Placebo | -1.9 | -2.0 | 2.5 | -11.3 |
| Zonisamide 200 mg | 4.1 | 1.7 | 1.5 | 0.7 |
| Zonisamide 400 mg | -0.1 | -0.3 | 3.4 | -11.7 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | kilograms (Least Squares Mean) |
|---|---|
| Olanzapine | 2.76 |
| Olanzapine + Amantadine | 2.40 |
| Olanzapine + Metformin | 0.65 |
The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126. (NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 48.24 | -13.89 |
| Olanzapine + Amantadine | 45.90 | -9.90 |
| Olanzapine + Metformin | 47.00 | -9.72 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). (NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 4.06 | -0.98 |
| Olanzapine + Amantadine | 4.03 | -0.72 |
| Olanzapine + Metformin | 4.00 | -0.79 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 12.76 | -6.39 |
| Olanzapine + Amantadine | 14.22 | -4.12 |
| Olanzapine + Metformin | 15.40 | -4.36 |
To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups. (NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | correlation (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| EI: Disinhibition | EI: Cognitive Restraint | EI: Hunger | FCI: Carbohydrates/Starches (N=186, N=141) | FCI: Fast Food Fats (N=188, N=140) | FCI: High Fats (N=186, N=138) | FCI: Sweets (N=187, N=140) | FCI: Total Score (N=184, N=137) | |
| 2 Weeks | -0.034 | -0.273 | -0.150 | 0.013 | -0.019 | 0.051 | 0.022 | 0.039 |
| 22 Weeks | 0.285 | -0.038 | 0.148 | -0.064 | 0.047 | 0.043 | -0.008 | -0.000 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | millimole per Liter (mmol/L) (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 5.32 | 0.26 |
| Olanzapine + Amantadine | 5.25 | 0.10 |
| Olanzapine + Metformin | 5.28 | 0.01 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | millimole per liter (mmol/L) (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 1.25 | -0.00 |
| Olanzapine + Amantadine | 1.26 | -0.11 |
| Olanzapine + Metformin | 1.22 | -0.08 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | millimole per Liter (mmol/L) (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 3.02 | 0.16 |
| Olanzapine + Amantadine | 3.06 | -0.04 |
| Olanzapine + Metformin | 2.91 | -0.02 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | millimole per Liter (mmol/L) (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 5.01 | 0.36 |
| Olanzapine + Amantadine | 5.03 | 0.01 |
| Olanzapine + Metformin | 4.91 | -0.08 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | millimoles per Liter (mmol/L) (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 1.58 | 0.33 |
| Olanzapine + Amantadine | 1.61 | 0.35 |
| Olanzapine + Metformin | 1.68 | 0.06 |
(NCT00401973)
Timeframe: Baseline to endpoint (22 weeks)
| Intervention | percent hemoglobin A1c (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Olanzapine | 5.51 | 0.09 |
| Olanzapine + Amantadine | 5.48 | 0.10 |
| Olanzapine + Metformin | 5.53 | -0.03 |
1 review available for zonisamide and Weight Gain
| Article | Year |
|---|---|
The first line of therapy in a girl with juvenile myoclonic epilepsy: should it be valproate or a new agent?
Topics: Anticonvulsants; Congenital Abnormalities; Delayed-Action Preparations; Drug Design; Epilepsy, Gener | 2009 |
4 trials available for zonisamide and Weight Gain
| Article | Year |
|---|---|
The effect of zonisamide on antipsychotic-associated weight gain in patients with schizophrenia: a randomized, double-blind, placebo-controlled clinical trial.
Topics: Adult; Antipsychotic Agents; Body Mass Index; Double-Blind Method; Female; Follow-Up Studies; Humans | 2013 |
Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment.
Topics: Adult; Anti-Obesity Agents; Anticonvulsants; Body Mass Index; Cohort Studies; Combined Modality Ther | 2014 |
Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study.
Topics: Adolescent; Adult; Aged; Algorithms; Amantadine; Antipsychotic Agents; Benzodiazepines; Clinical Pro | 2012 |
A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain.
Topics: Adult; Anticonvulsants; Antipsychotic Agents; Benzodiazepines; Bipolar Disorder; Cognition Disorders | 2012 |
2 other studies available for zonisamide and Weight Gain
| Article | Year |
|---|---|
Zonisamide produces weight loss in psychotropic drug-treated psychiatric outpatients.
Topics: Adult; Female; Humans; Isoxazoles; Male; Mental Disorders; Middle Aged; Outpatients; Overweight; Psy | 2011 |
Zonisamide prevents olanzapine-associated hyperphagia, weight gain, and elevated blood glucose in rats.
Topics: Animals; Anticonvulsants; Appetite Regulation; Benzodiazepines; Biomarkers; Body Weight; Diabetes Me | 2008 |