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tamoxifen added to litihium in patint with acute mania

A double - blind placebo controlled traial of tamoxifen added to litihium in patint with acute mania

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT1138901151556N12
Enrollment
40
Registered
2010-04-29
Start date
2010-03-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mania episode. Mania episode

Interventions

Intervention 1: Intervension: Risperidone tablet(4 mg/day) combined with tamoxifen tablet (80 mg/day) + lithium tablet 1800mg/day as intervention group for 6 weeks. Intervention 2: Control group: Risp
Treatment - Drugs
Intervension: Risperidone tablet(4 mg/day) combined with tamoxifen tablet (80 mg/day) + lithium tablet 1800mg/day as intervention group for 6 weeks
Control group: Risperidone tablet (4 mg/day) combined with placebo tablet + lithium tablet 1800mg/day as control group for 6 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients aged between 18 and 49 wioll be eligible to participate, as they meet the DSM-IV criteria for a current manic episode, on the basis of a clinical interview by two academician psychiatrists. In addition, a score of at least 20 points on the YoungMania Rating Scale will be required representing at least a moderate-to-severe mania. Exclusion criteria: Other diagnosis in Axix 1, substance dependence, severe medical problems and lactating and pregnant women.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Score of Young Mania Rating Scale. Timepoint: evey two weeks from the begining of trial till week 8. Method of measurement: by Young Mania Rating Scale.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026