None listed
Conditions
Interventions
Drug : 1. All patients in open-label phase will be treated with one antidepressant (Escitalopram or Bupropion XL) in combination with either:
1) one or two mood stabilizerstabilizers (Lithium or D
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Open-label phase 1) Diagnosed with BD, current episode depressed, with a MADRS score = 20 at both the screening and baseline assessments. 2) The duration of the current depressive episde is = 2 weeks but = 52 weeks. 3) Taking or initiating treatment with an anti-manic medication at a therapeutic dose. Anti-manic medications and therapeutic doses are: Lithium, serum level 0.6-1.4 mEq/L; Divalproex, serum level 350-700 mM; Risperidone 1-6 mg/day; Olanzapine 5-30 mg/day; Quetiapine IR or XR 300-900 mg/day; Aripiprazole 10-30 mg/day; and Ziprasidone 80- 160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with Lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus Asenapine, 5-20 mg/day, are also permitted. 4) If taking any other psychoactive medication(other than Lorazepam = 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of = 4 weeks. 5) If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation. 6) Fluent in Korean and capable of providing informed consent. 7) Aged 18-70 years, inclusive. 2. Double-blind phase 1) Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to either a mood stabilizing medication (Lithium, serum level 0.6- 1.2 mEq/L, Divalproex, serum level 350-700 mM, Carbamazepine, serum level 20- 50 umol/L), a second generation antipsychotics(Risperidone 1-6 mg/day; Olanzapine 5-30 mg/day; Quetiapine IR or XR 150-900 mg/day; Aripiprazole 10- 30 mg/day; Ziprasidone 80-160 mg/day), two mood stabilizers, a mood stabilizer plus a second generation antipsychotics (including Asenapine 5- 20 mg/day), or a mood stabilizer or second generation antipsychotics plus Lamotrigine (100-400 mg/day). 2) Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for = 2 weeks and = 8 weeks. 3) If female and of childbearing potential, is using an adequate method of contraception.
Exclusion criteria
Exclusion criteria: 1. Open-label phase 1) Has a history cycling, defined as = 4 mood episodes in the preceding 12 months. 2) Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score = 8 at the screening or baseline visits. 3) Has previously been refractory to treatment with both Escitalopram and Bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction. 4) Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study. 5) Is at high risk for suicide, as defined by a score of = 4 on the suicide item of the MADRS, or in the opinion of the investigator. 6) Has an unstable meidcal illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator. 7) Is pregnant or lactating. 8) Is taking monoamine oxidase inhibitors, such as Phenelzine or Tranylcypromine. 9) Escitalopram is contraindicated in patients taking the antipsychotic medications Pimozide or Ziprasidone. Patients on Pimozide or Ziprasidone can participate in the study and will be prescribed Bupropion XL. 10) Bupropion XL is contraindicated in patients taking other preparations containing Bupropion, such as Zyban and Wellbutrin SR; in patients with active eating disorders, including anorexia nervosa and bulimia nervosa; and in patients with seizure disorders. Patients with any of these can still participate in the study and will be prescribed Escitalopram. 11) Has significant abnormalities on an electrocardiogram. 2. Double-blind phase 1) The criteria are the same as open-label phase. In addition, patients have experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of = 16, or in the opinion of the study psychiatrist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean improvement in MADRS(Montgomery-Asberg Depression Rating Scale) score from baseline to endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in IDS(Inventory of Depressive Symptoms Scales)-CR(Clinician rating) and IDS-S(self) scores;Improvement in HAM-A scores;Rates of response, defined as = 50% improvement in baseline MADRS score;Rates of remission, defined as a MADRS score = 8 and YMRS score = 8 for = 2 weeks, or a score of = 2 (borderline mentally ill) on the CGI-S- BD for = 2 weeks;Rates of treatment-emergent mania and hypomania, YMRS score = 16 for hypomania and = 20 for mania at any study visit;Overall psychiatric status and overall improvement, using the CGI-S-BD and CGI-I-BD scales;Rates of adverse events (AEs) and serious adverse events (SAEs), using the MDCSES(Mood Disorders Centre Side Effects Scale );Quality of life, using the Q-LES-Q(Quality of Life, Enjoyment, and Satisfaction Questionnaire ) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Hyon Ha
Seoul National University Bundang Hospital
Outcome results
None listed