The response of 62 outpatients with DSM-IV bipolar disorders to open-label adjunctive zonisamide was evaluated in a prospective 8-week acute trial, followed by a 48-week continuation trial, conducted from June 2001 through May 2002.
During the acute trial, response to zonisamide was assessed weekly for the first 4 weeks and every 2 weeks for the second 4 weeks with the Clinical Global Impressions scale modified for bipolar illness (CGI-BP), the Young Mania Rating Scale (YMRS), and the Inventory for Depressive Symptomatology (IDS). During the continuation trial, patients were assessed with these scales every 4 weeks. Patients' weights and side effects were also evaluated. Outcome measures were analyzed with repeated-measures analyses of variance.
Patients with manic symptoms at study entry (N = 34) displayed significant reductions in CGI-BP-Mania Severity and YMRS scores in the acute and continuation (N = 19) trials (p values < .0001 and < .001, respectively). Patients with depressive symptoms at study entry (N = 22) showed significant decreases in CGI-BP-Depression Severity and IDS scores in the acute trial (p values < .001 and < .05, respectively), but only 9 patients entered the continuation trial. Among these 9 patients, maintenance of anti-depressant response was mostly maintained. Initially euthymic patients (N = 6) showed no change in any rating scale scores acutely, but 2 of 4 patients who entered the continuation trial developed depressive symptoms. The 62 patients as a group showed significant weight loss in both trials (p values < .001). However, 20 patients (32%) discontinued zonisamide for worsening mood symptoms.
Adjunctive zonisamide was associated with beneficial effects on mood and body weight in some patients with bipolar disorders, but was also associated with a high discontinuation rate due to worsening mood symptoms. Double-blind, placebo-controlled studies are necessary to determine zonisamide's thymoleptic properties, if any, in bipolar disorders.
"The broad pharmacodynamic properties of zonisamide suggest that they have potential effects on other neuropsychiatric disorders. Several clinical trials have investigated the effectiveness of zonisamide on migraines (Ashkenazi et al., 2006; Drake et al., 2004), chronic pain (Krusz, 2003), bipolar affective disorder (Berigan, 2002; Ghaemi et al., 2008; McElroy et al., 2005; Wang et al., 2008), binge eating disorder (McElroy et al., 2006), and obesity(Gadde et al., 2003; McElroy et al., 2006; Wang et al., 2008; Yang et al., 2010). "
[Show abstract][Hide abstract] ABSTRACT: This study examined the long-term effectiveness and tolerability of zonisamide for weight control in psychiatric outpatients using various psychotropic medications. We conducted a systematic chart review of 82 psychiatric outpatients with unwanted weight gain after the introduction of psychotropic drugs between January 2008 and September 2009 at Korea University Ansan Hospital. The primary outcome measure was the effect of zonisamide on body mass index (BMI). Additional outcome measures included safety and tolerability as assessed by the clinical global impression-severity of illness scale (CGI-S) and discontinuation rate. The mean final dose of zonisamide was 124.6±53.4 mg/day and ranged from 50mg/day to 300 mg/day. The mean BMI reduction was 0.8±1.7 kg/m(2) and ranged from -2.9 kg/m(2) to 4.7 kg/m(2) (p<0.001). We also observed a significant reduction in CGI-S scores from the baseline (3.8±0.9) to the endpoint (3.3±0.8; p<0.001). Twelve patients (14.6%) discontinued their zonisamide treatment due to its side effects. Patients treated with zonisamide showed significant weight loss. Furthermore, its treatment was generally safe and well tolerated with few negative effects on patients' overall psychiatric symptoms. Additional research is required to confirm these results and to investigate whether patients have rebound weight gains after discontinuing zonisamide.
Progress in Neuro-Psychopharmacology and Biological Psychiatry 07/2011; 35(8):1918-21. DOI:10.1016/j.pnpbp.2011.07.007 · 3.69 Impact Factor
"Venlafaxine up to 375 mg/d L-Thyroxine ϩ ongoing treatment C1 4 (Bauer et al. 1998; Bauer et al. 2005) L-Thyroxine: Up to 450 mcg Topiramate ϩlithium or valproate C1 4 (McIntyre et al. 2002) Topiramate: 50–300 mg Zonisamide ϩ lithium or valproate C1 4 (McElroy et al. 2005; Baldassano et al. 2004; Wilson and Findling 2007; Ghaemi et al. 2006b "
[Show abstract][Hide abstract] ABSTRACT: These guidelines are based on a first edition that was published in 2002, and have been edited and updated with the available scientific evidence until September 2009. Their purpose is to supply a systematic overview of all scientific evidence pertaining to the treatment of acute bipolar depression in adults.
The data used for these guidelines have been extracted from a MEDLINE and EMBASE search, from the clinical trial database clinicaltrials.gov, from recent proceedings of key conferences, and from various national and international treatment guidelines. Their scientific rigor was categorised into six levels of evidence (A-F). As these guidelines are intended for clinical use, the scientific evidence was finally assigned different grades of recommendation to ensure practicability.
We identified 10 pharmacological monotherapies or combination treatments with at least limited positive evidence for efficacy in bipolar depression, several of them still experimental and backed up only by a single study. Only one medication was considered to be sufficiently studied to merit full positive evidence.
Although major advances have been made since the first edition of this guideline in 2002, there are many areas which still need more intense research to optimize treatment. The majority of treatment recommendations is still based on limited data and leaves considerable areas of uncertainty.
The World Journal of Biological Psychiatry 02/2010; 11(2):81-109. DOI:10.3109/15622970903555881 · 4.18 Impact Factor
"Oxcarbazepine may also exhibit both interactions with other medications and tolerability issues, but to a lesser degree than carbamazepine; however, the risk of hyponatremia appears to be greater with oxcarbazepine. Other anticonvulsants with CE of efficacy ''C1'' 4 include levetiracetam (Goldberg and Burdick 2002; Grunze et al. 2003b; Kyomen 2006; Desarkar et al. 2007) and zonisamide (Kanba et al. 1994; McElroy et al. 2005; Anand et al. 2005). One small case series (Amann et al. 2006) gives retigabine ''C1'' evidence. "
[Show abstract][Hide abstract] ABSTRACT: These updated guidelines are based on a first edition that was published in 2003, and have been edited and updated with the available scientific evidence until end of 2008. Their purpose is to supply a systematic overview of all scientific evidence pertaining to the treatment of acute mania in adults. The data used for these guidelines have been extracted from a MEDLINE and EMBASE search, from the clinical trial database clinicaltrials.gov, from recent proceedings of key conferences, and from various national and international treatment guidelines. Their scientific rigor was categorised into six levels of evidence (A-F). As these guidelines are intended for clinical use, the scientific evidence was finally asigned different grades of recommendation to ensure practicability.
The World Journal of Biological Psychiatry 05/2009; 10(2):85-116. DOI:10.1080/15622970902823202 · 4.18 Impact Factor
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