Evidence map›Paper›PMID 27346789›Full record

ArticleClinical and translational science2016

Endoxifen, a New Treatment Option for Mania: A Double-Blind, Active-Controlled Trial Demonstrates the Antimanic Efficacy of Endoxifen.

A Ahmad, S Sheikh, T Shah, M S Reddy, Bsv Prasad, K K Verma, B B Chandrakant, M Paithankar, P Kale, R V Solanki and 3 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD).Degenerative neurological and neuromuscular disease · 2025
    Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. The Use of Tamoxifen as a Potential Treatment for Bipolar Disorder.Psychiatry and clinical psychopharmacology · 2021
    Article
  13. Valproate for acute mania.The Cochrane database of systematic reviews · 2019
    Review
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

A AhmadJina Pharmaceuticals Inc, Libertyville, Illinois, USA.
S SheikhJina Pharmaceuticals Inc, Libertyville, Illinois, USA.
T ShahDivyam Hospital, Surat, GJ, India.
M S ReddyAsha Hospital, Hyderabad, AP, India.
Bsv PrasadSujata Birla Hospital and Medical Research Centre, Nashik, MH, India.
K K VermaS. P. Medical College & A G Hospitals, Bikaner, RJ, India.
B B ChandrakantShri Hatkesh Healthcare Foundation, Junagadh, GJ, India.
M PaithankarIntas Pharmaceuticals Ltd, Ahmedabad, GJ, India.
P KaleLambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
R V SolankiLambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
R PatelLambda Therapeutic Research Ltd, Ahmedabad, GJ, India.
H BarkateIntas Pharmaceuticals Ltd, Ahmedabad, GJ, India.
I AhmadJina Pharmaceuticals Inc, Libertyville, Illinois, USA.
Lake County Forest Preserves · USLambda Therapeutic Research (India) · INIntas Pharmaceuticals (India) · INAsha Hospital · INJunagadh Agricultural University · INSardar Patel Medical College · INSujata Birla Hospital and Medical Research Center · INSurya Hospitals · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The protein kinase C (PKC) signaling system plays a role in mood disorders and PKC inhibitors such as endoxifen may be an innovative medicine for bipolar disorder (BP) patients. In this study we show for the first time the antimanic properties of endoxifen in patients with bipolar I disorder (BPD I) with current manic or mixed episode. In a double-blind, active-controlled study, 84 subjects with BPD I were randomly assigned to receive endoxifen (4 mg/day or 8 mg/day) or divalproex in a 2:1 ratio. Patients orally administered 4 mg/day or 8 mg/day endoxifen showed significant improvement in mania assessed by the Young Mania Rating Scale as early as 4 days. The effect remained significant throughout the 21-day period. At study end point, response rates were 44.44% and 64.29% at 4 mg/day and 8 mg/day of endoxifen treatment, respectively. Thus, endoxifen has been shown as a promising novel antimanic or mood stabilizing agent.

Identifiers

PMID27346789
PMCPMC5350997
OpenAlexW2469455427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.