Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania
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| ClinicalTrials.gov Identifier: NCT01893229 |
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Recruitment Status : Unknown
Verified March 2015 by Guiyun Xu, Guangzhou Psychiatric Hospital.
Recruitment status was: Recruiting
First Posted : July 8, 2013
Last Update Posted : March 17, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Lithium Drug: Valproate Drug: Oxcarbazepine Drug: Quetiapine Drug: Olanzapine Drug: Ziprasidone | Phase 4 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Efficacy and Acceptability of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, and Ziprasidone in Bipolar I Disorder, Manic or Mixed Phase |
| Study Start Date : | September 2013 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Valproate
Name: Valproate; dosage form: tablet, 250mg; dosage and frequency: 800mg-- 1200mg/d; duration: 6 weeks.
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Drug: Valproate
Valproate is used as a mood stabiliser
Other Name: Depakote |
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Experimental: Oxcarbazepine
Name: Oxcarbazepine, dosage form: 300mg, tablet; dosage and frequency: 600-1200mg/d; duration: 6 weeks
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Drug: Oxcarbazepine
Oxcarbazepine is used as a mood stabiliser
Other Name: Trileptal |
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Experimental: Quetiapine
name: Quetiapine, dosage form: 200mg,tablet; dosage and frequency: 600mg-- 800mg/d; duration: 6 weeks
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Drug: Quetiapine
Quetiapine is used as a mood stabiliser
Other Name: SEROquel |
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Experimental: Olanzapine
Name: Olanzapine, dosage form: 5mg tablet; dosage and frequency: 10mg--20mg/d; duration: 6 weeks
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Drug: Olanzapine
Olanzapine is used as a mood stabiliser.
Other Name: Zyprexa； |
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Experimental: Ziprasidone
Name: Ziprasidone, dosage form: 10mg tablet; dosage and frequency: 80mg-160mmg/d; duration: 6 weeks
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Drug: Ziprasidone
Ziprasidone is used as a mood stabiliser
Other Name: Geodon |
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Experimental: Lithium
name: lithium; dosage form: 250mg Tablet; dosage and frequency: 750mg-2000mg/d;serum Li level: 0.6mmol-1.2mmol/L; duration: 6 weeks
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Drug: Lithium
Lithium is used as a mood stabiliser
Other Name: lithium Carbonate |
- Change from baseline in Young Mania Rating Scale at 2 weeks and 6 weeks [ Time Frame: Baseline, 2 weeks and 6 weeks ]Young Mania Rating Scale is used to assess hypomania/mania symptoms
- rate of dropout (treatment discontinuation) [ Time Frame: 1,2,4,6 weeks ]to compare the rates of treatment discontinuation of different drugs because of side effect or effectiveness
- Clinical Global Impressions (CGI) Scale [ Time Frame: baseline, 2 weeks, 4 weeks, and 6 weeks ]Clinical Global Impressions (CGI) Scale is used to assess the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure, taking into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function
- Brief Psychiatric Rating Scale [ Time Frame: baseline, 2, 3, 4 and 6 weeks ]Brief Psychiatric Rating Scale is used to assess psychotic symptoms.
- Global Assessment Scale [ Time Frame: baseline, 2, 3, 4 and 6 weeks ]Global Assessment Scale is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning.
- Treatment Emergent Symptom Scale [ Time Frame: 2, 3, 4 and 6 weeks ]Treatment Emergent Symptom Scale is used to assess the adverse event of the drug.
- Hamilton Anxiety Rating Scale [ Time Frame: baseline, 2, 3, 4, and 6 weeks ]Hamilton Anxiety Rating Scale is used to assess anxious symptoms
- Hamilton Depression Rating Scale [ Time Frame: baseline, 2, 3, 4, and 6 weeks ]Hamilton Depression Rating Scale is used to assess the depressive symptoms
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- with a diagnosis of bipolar I disorder, manic or mixed phase
- equal or more than 18 scores in Young Mania Rating Scale (YMRS)
Exclusion Criteria:
- Serious general medical illness
- pregnancy and lactation
- given long-acting antipsychotic drug within the last two month
- endocrine disease( e.g.Diabetes and thyrotoxicosis)
- given thyroxine therapy within the last three months or is being given hormone therapy
- sexually active and not using contraceptives
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893229
| Contact: Guiyun Xu, MD | 86(02081891425) ext 8111 | xuguiyun2908@hotmail.com |
| China, Guangdong | |
| Guangzhou Psychiatric Hospital | Enrolling by invitation |
| Guangzhou, Guangdong, China, 510370 | |
| Guangzhou Psychiatric Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510370 | |
| Contact: Guiyun Xu, M.D xuguiyun2908@hotmail.com | |
| Principal Investigator: Guiyun Xu, M.D | |
| Principal Investigator: | Guinyun Xu, M.D | Guangzhou Psychiatric Hospital | |
| Principal Investigator: | Kangguang Lin, M.D | The University of Hong Kong |
| Responsible Party: | Guiyun Xu, Associate Professor, Guangzhou Psychiatric Hospital |
| ClinicalTrials.gov Identifier: | NCT01893229 |
| Other Study ID Numbers: |
20120509 |
| First Posted: | July 8, 2013 Key Record Dates |
| Last Update Posted: | March 17, 2015 |
| Last Verified: | March 2015 |
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Bipolar disorder Comparative Effectiveness Research Therapeutics Patient Dropouts |
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Bipolar Disorder Bipolar and Related Disorders Mood Disorders Mental Disorders Oxcarbazepine Valproic Acid Olanzapine Quetiapine Fumarate Ziprasidone Lithium Carbonate Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Selective Serotonin Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents Enzyme Inhibitors Antimanic Agents Anticonvulsants GABA Agents |