Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Background:
Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the
population, and one of the leading causes of worldwide disability. Mania is a condition of
excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of
hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance
treatment of acute mania with and without psychotic symptoms. Though clinical trails have
been demonstrated that these drugs are individually more effective than placebo in the
relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute
mania urgently want to see the effectiveness, and psychiatrist under great pressure and are
in great need to evaluate the very short-term effectiveness (e.g one week). If the first
attempted antimanic drug fails, psychiatrist need the evidence that which medication should
be to added on or switch to.
Objectives:
one main aim is to rank the short-term ( e.g.one and two week) effectiveness and
acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine,
Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to
add on for non-responders or switch to.
Methods:
The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I
disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric
hospital in the history of China established by Dr.J. G. Kerr in 1898.
Design:This study is a randomized, controlled trial. Participants with a Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I
disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium,
Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following
conditions, participants will take another antimanic drug as a combination medication: 1)
those who have a reduction in YMRS scores less than 25% after one week of treatment; 2) those
who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3) those
who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine, Olanzapine,
and Ziprasidone) will be added on for those who use lithium, Valproate or Oxcarbazepine as a
first attempted medication; while Lithium, Valproate, or Oxcarbazepine will be added on for
those who use an antipsychotic as a first attempted medication. Those participants who are
recognized as non-response/partial response to two combined medications after 6 weeks of
treatment will switch to Modified Electroconvulsive Therapy (MECT).
Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS)
and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI)
Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief
Psychiatric Rating Scale (BPRS).
Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as
non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of Clinical
General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS as well
as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as response.
Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.