Evidence map›Paper›PMID 37933420›Full record

Trial reportBrain and behavior2023

Efficacy of spironolactone as adjunctive therapy to sodium valproate in bipolar-I disorder: A double-blind, randomized, placebo-controlled clinical trial.

Atefeh Zandifar, Rahim Badrfam, Fatemeh Gholamian, Arman Shafiee

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brain and behavior, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Atefeh ZandifarSocial Determinants of Health Research Center, Alborz University of Medical Sciences, Karaj, Iran.ORCID 0000-0002-4725-1734
Rahim BadrfamDepartment of Psychiatry, Imam Hossein Hospital, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.ORCID 0000-0001-9808-1678
Fatemeh GholamianSchool of Medicine, Alborz University of Medical Sciences, Karaj, Iran.
Arman ShafieeClinical Research Development Unit, Alborz University of Medical Sciences, Karaj, Iran.ORCID 0000-0002-1941-4399
Jahrom University of Medical Sciences · IRImam Hossein Hospital · IR

Funding

Alborz University of Medical Sciences IR.ABZUMS.REC.1399.319
6 · The paper itself

Abstract

introductionTreatment of mood and cognitive symptoms of patients with bipolar disorder is associated with many complications and is generally not associated with therapeutic satisfaction. In this clinical trial, we evaluated the effectiveness of spironolactone in controlling mood and cognitive symptoms, sleep quality, appetite, and body mass index in patients with bipolar disorder in manic episodes.

methodsSixty inpatients with bipolar disorder in manic episodes were treated with spironolactone/placebo in an 8-week randomized, double-blind, placebo-controlled clinical trial. They were evaluated using the Young Mania Rating Scale (YMRS), mini-mental state examination (MMSE), Pittsburgh sleep quality index, Simplified Nutritional Appetite Questionnaire, and body mass index in weeks 1, 4, and 8.

resultsFor cognitive impairment (MMSE), there were significant interaction effects of group and time at week 8 (B = -1.60, SE = 0.69, t = -2.33, p = .021) such that individuals in the spironolactone group experienced more improvement in their cognitive performance. For manic symptoms (YMRS), there were no significant interaction effects of group and time at week 8 (B = -2.53, SE = 1.46, t = -1.73, p = .085).

conclusionsConsidering the promising findings in this clinical trial, further study of spironolactone as adjunctive therapy in bipolar disorder in manic episodes with larger sample sizes, multicenter settings, and longer follow-ups are recommended.

Indexed as

Bipolar DisorderDouble-Blind MethodDrug Therapy, CombinationHumansManiaPsychiatric Status Rating ScalesSpironolactoneTreatment OutcomeValproic AcidSpironolactoneValproic Acidbipolar disordercognitionhypothalamus-pituitary-adrenal axisspironolactone

Identifiers

PMID37933420
PMCPMC10726882
OpenAlexW4388459744

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.