Q: Is Quetiapine 600 mg Superior to 300 mg for Bipolar I and II Depression?

 

The following two double blind randomized trails will answer this question.

 

ARTICLE 1:

This randomized, double-blind, placebo-controlled trial published by Calabrese et al (2005) compared the efficacy of Quetiapine in both bipolar I and II disorder

 

PARTICIPANTS:

  • 542 patients with bipolar I (N=360) or II (N=182) disorder experiencing a major depressive episode (DSM-IV)

  • Randomly assigned to 8 weeks of quetiapine (600 or 300 mg/day) or placebo.

 

PRIMARY EFFICACY MEASURE:

Mean change from baseline to week 8 in the MADRS total score.

  • Response criteria: > or =50% MADRS score improvement.

  • Remission criteria: MADRS score < or =12.

 

RESULTS:

1. Proportions of patients meeting response criteria:

  • Quetiapine 600 mg/day = 58.2%.

  • Quetiapine 300 mg/day = 57.6%.

  • Placebo = 36%.

 

2. Proportions of patients meeting remission criteria:

  • Quetiapine 600 mg/day = 53%.

  • Quetiapine 300 mg/day = 53%.

  • Placebo = 28%.

 

3. Improvement in MADRS items:

  • Quetiapine 600 mg/day: significantly improved 9/10 MADRS items.

  • Quetiapine 300 mg/day: significantly improved 8/10 MADRS items.

  • The core mood symptoms of apparent sadness, reported sadness, and pessimistic thoughts were significantly improved in both Quetiapine groups as early as week 1 compared with placebo (p<0.05).

 

4.  Discontinuation due to adverse events:

  • Quetiapine 600 mg/day: 26% (N=47)

  • Quetiapine 300 mg/day: 16% (N=29)

  • Placebo: 8.8% (N=16)

 

CONCLUSION:

  • For response and remission rate: Quetiapine 300 mg dose is almost equal in effectiveness to 600 mg dose.

  • Adverse Effects: increases at 600 mg daily dose resulting in more discontinuation rate.

 

SOURCE:

 


 

ARTICLE 2:

This second article published by Young et al (2013) is focused on efficacy of Quetiapine monotherapy for depressive episodes in patients with bipolar II disorder.

 

PARTICIPANTS:

  • All studies included an 8-week, double-blind treatment phase in which

  • Patients were randomly assigned to treatment with quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo.

 

OUTCOME MEASURE:

  • Change from baseline in MADRS total score at week 8

  • Effect sizes and

  • MADRS response and remission rates.

 

RESULTS:

1. Mean change in MADRS total score from baseline to week 8: mean [SE]

  • Quetiapine 600mg/day = −14.88 [0.62] 

  • Quetiapine 300 mg/day = −15.58 [0.62] 

  • Placebo = −11.61 [0.70]

 

2. Effect sizes based on MADRS scores:

  • Quetiapine 600mg/day = 0.47

  • Quetiapine 300 mg/day = 0.44

 

3. Remission rate:

  • Quetiapine 600mg/day = 61%

  • Quetiapine 300 mg/day = 65%

  • Placebo = 46%

 

4. Discontinuation due to adverse events:

  • Quetiapine 600 mg/day: 18%

  • Quetiapine 300 mg/day: 12%

  • Placebo: 5%

 

CONCLUSION:

  • For Bipolar II disorder, Quetiapine 300 mg dose is almost equal in effectiveness to 600 mg dose.

  • Note the higher remission rates for 300 mg daily dose.

  • Again increase in adverse effects were noted at 600 mg daily dose resulting in more discontinuation rate.

 

SOURCE:


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Dr. Harvinder Singh, M.D. (Admin)


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