Major Depressive Disorder

• CLINICAL_TRIALS trial_result · 2021-03-15
  Clinical Trial Update: A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD) [Phase 3]

  Phase 3 trial update for ALKS 5461 in treatment-refractory major depressive disorder completed with results posted.

• FDA approval · 2021-03-12
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Solco Healthcare US LLC)

  The FDA approved a supplemental application for a generic version of Bupropion hydrochloride sustained-release from Solco Healthcare US LLC …

• CLINICAL_TRIALS trial_result · 2021-03-10
  Clinical Trial Update: Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults [Phase 2, Phase 3]

  A clinical trial update for Meru Health Ascend mobile intervention targeting depression in middle-aged and older adults, completed phases 2 …

• FDA approval · 2021-03-09
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  FDA approved the original application for doxepin hydrochloride (generic) from Leading Pharma, LLC, for use in treating depressive disorders…

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for the generic olanzapine/fluoxetine combination, expanding access to this treatment.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. The combination is indicated for depressive ep…

• FDA approval · 2021-02-24
  FDA Approved: NORTRIPTYLINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved an original application for Nortriptyline Hydrochloride as a generic product by Zydus Lifesciences Limited.

• CLINICAL_TRIALS trial_result · 2021-02-23
  Clinical Trial Update: The Antidepressive Effect of rTMS as add-on to ECT [NA]

  A terminated clinical trial investigating the antidepressive effect of rTMS as an add-on to ECT in depression.

• FDA approval · 2021-02-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA-approved Amitriptyline hydrochloride as a generic product via Original Application by Lifestar Pharma LLC.

• CLINICAL_TRIALS trial_result · 2021-02-16
  Clinical Trial Update: The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity [Phase 3]

  Phase 3 clinical trial investigating the effects of probiotic supplementation on depressive symptoms, inflammation, oxidative stress, and gu…

• FDA approval · 2021-02-16
  FDA Approved: PAROXETINE — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' generic paroxetine (PAROXETINE) via an Original Application (ANDA213485). It covers indication…

• CLINICAL_TRIALS trial_result · 2021-02-12
  Clinical Trial Update: Title: Evaluation of a Novel PET Radioligand for Phosphodiesterase-4D (PDE4D) [Phase 1, Phase 2]

  Phase 1/2 clinical trial evaluating a novel PET radioligand targeting PDE4D for depression; study completed with results posted.

• CLINICAL_TRIALS trial_result · 2021-02-09
  Clinical Trial Update: Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial [Phase 4]

  Phase 4 trial investigating metformin, vitamin D, and depression in polycystic ovary syndrome was terminated; results posted previously.

• CLINICAL_TRIALS trial_result · 2021-02-09
  Clinical Trial Update: Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

  Post-marketing surveillance study assessing effectiveness and safety of Pristiq (desvenlafaxine) in major depressive disorder completed with…

• FDA approval · 2021-02-06
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Paxil (paroxetine hydrochloride) submitted by Apotex Corp.

• FDA approval · 2021-02-05
  FDA Approved: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA supplemental approval for a generic chlordiazepoxide and amitriptyline hydrochloride product from Mylan Pharmaceuticals.

• FDA approval · 2021-02-04
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine from Par Health USA, LLC. The …

• CLINICAL_TRIALS trial_result · 2021-02-04
  Clinical Trial Update: Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment [Phase 2, Phase 3]

  Phase 2/3 FEAST trial updates completed at two sites evaluating Focal Electrically-Administered Seizure Therapy for depression.

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARIPIPRAZOLE from Alembic Pharmaceuticals Inc., authorizing a generic aripiprazole product. The …

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.

• CLINICAL_TRIALS trial_result · 2021-01-29
  Clinical Trial Update: Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide [Phase 3]

  A Phase 3 trial comparing lithium to paroxetine in patients with major depressive disorder and a family history of bipolar disorder or suici…

• CLINICAL_TRIALS trial_result · 2021-01-28
  Clinical Trial Update: A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression. [Phase 2]

  Phase 2 trial comparing sertraline-reboxetine combination to sertraline or reboxetine monotherapy for major depressive disorder has complete…

• CLINICAL_TRIALS trial_result · 2021-01-27
  Clinical Trial Update: A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression [Phase 4]

  Phase 4 trial comparing sertraline to venlafaxine XR in adults with major depressive disorder has completed.

• CLINICAL_TRIALS trial_result · 2021-01-26
  Clinical Trial Update: Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients [Phase 4]

  Phase 4 clinical trial evaluating quality of life and self-esteem after Botox injections in depressed and non-depressed patients.

• FDA approval · 2021-01-22
  FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for TRINTELLIX (vortioxetine) submitted by Takeda Pharmaceuticals America, Inc.