New Orleans – Low-dose administration of cariprazine (Vraylar) was associated with reduced anxiety in patients with major depressive disorder (MDD), and a potential adjuvant therapy for this population also showed improvement in most individual symptoms of depression, according to two post-dose treatment. Analyzes for a phase III trial.
When combined with an antidepressant for MDD patients who had an inadequate response to monotherapy, a 1.5 mg daily dose of cariprazine showed a significant reduction in anxiety compared to placebo in the overall Hamilton Anxiety Scale (HAM-A) score, as measured. Least squares mean difference (LSMD) from baseline.
At Week 6, patients taking the 1.5 mg dose had a reduction of 9.1 compared to a reduction of 7.8 in the placebo group (LSMD -1.30, 95% CI -2.47 to -0.08, nominal). s= 0.037), reported Vladimir Malech, MD, MSc, of the University of South Carolina School of Medicine in Greenville, during a poster presentation at Psychological Congress. No significant difference versus placebo was observed among the trial participants who received the 3 mg daily dose.
The second analysis, also presented by Maletic, showed significant improvements with cariprazine across eight of the 10 components of the Montgomery-Åsberg Depression Rating Scale (MADRS) when the two-dose data were pooled together.
In people who have not responded to previous antidepressant treatments, if they received cariprazine [the] The implication is that it will provide not only help with depressive symptoms but will obviously result in a reduction in anxiety in patients with mild and moderate symptoms. [anxiety],” Tell MedPage today.
Preliminary results from a phase III trial – Study 3111-301-001 — they were I mentioned earlier this year At the annual meeting of the American Psychiatric Association. The trial met its primary end point, demonstrating that adjuvant cariprazine at a lower dose significantly reduced the overall MADRS score in those patients with MDD.
effect on anxiety
When study population data were grouped based on the severity of baseline anxiety, participants with at least mild anxiety (HAM-A score > 7) or at least moderate anxiety (> 14) had better outcomes with a lower dose of cariprazine compared with placebo
- Moderate: LSMD -1.3 (95% CI -2.52 to -0.10)
- Medium: LSMD -1.6 (95% CI -2.98 to -0.23)
Participants with severe anxiety (>23) at baseline seemed likely to derive greater benefit with any dose of cariprazine plus a background antidepressant, but the results were not significant, given the small sample size, according to Malletic.
We cannot say about the danger [anxiety] Because they are not statistically significant, but they are numerical indicators at least [show] All categories of anxious patients are likely to benefit from this combination, he said. MedPage today.
The analysis included 751 participants divided into three treatment groups – cariprazine 1.5 mg (n = 250), cariprazine 3 mg (n = 252), and placebo (n = 249) – each combined with an antidepressant treatment. At baseline, nearly all participants (98.8%) had at least mild anxiety. Of these, 82.6% had at least moderate anxiety, and 34.9% had severe anxiety.
Effect on MADRS components
Maletic reported that adjuvant cariprazine also produced significantly greater improvement across several MADRS scores for individual depression symptoms compared to placebo.
Significant improvements were seen versus placebo with a daily 1.5 mg dose for seven of the 10 MADRS symptoms, and the pooled data for both cariprazine doses showed a significant reduction in eight of the components:
- Pronounced sadness: LSMD -0.2 (95% CI -0.44 to -0.03, s= 0.0247)
- Reported sadness: LSMD -0.4 (95% CI -0.58 to -0.16, s= 0.0006)
- Low appetite: LSMD -0.3 (95% CI -0.50 to -0.10, s= 0.0036)
- Lassitude: LSMD -0.3 (95% CI -0.56 to -0.12, s= 0.0025)
- Inability to feel: LSMD -0.3 (95% CI -0.51 to -0.06, s= 0.0126)
- Pessimistic thoughts: LSMD -0.3 (95% CI -0.45 to -0.07, s= 0.0088)
- Suicidal thoughts: LSMD -0.1 (95% CI -0.20 to -0.02, s= 0.0127)
Cariprazine already has indications in schizophrenia and bipolar I disorder. Based on the results of the current study, developer AbbVie has provided a file Complementary new drug application For additional indication as adjunctive therapy for major depressive disorder in patients receiving ongoing antidepressant therapy.
The study was sponsored by AbbVie.
Maletic has reported financial relationships with AbbVie/Allergan, Acadia, Alfasigma, Alkermes, Axsome, Eisai-Purdue, Intra-Cellular, Ironshore, Janssen, Lundbeck A/S, Jazz Pharmaceuticals, Noven, Otsuka, Sage, Sunovion, Supernus and Takeda; The co-authors also stated that they are employees of or own stock/options in AbbVie.