The Treatment Effects of Antidepressant and Mood Stablizer in Bipolar Disorder Patients

Not Applicable

Recruiting

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0001192
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean improvement in MADRS(Montgomery-Asberg Depression Rating Scale) score from baseline to endpoint

Secondary Outcome Measures

Name	Time	Method
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 )