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Tamoxifen Effects in Acute mania in Youth

Investigation of efficacy of lithium and tamoxifen in the treatment of acute mania in bipolar affective disorder.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201410126418N3
Enrollment
44
Registered
2015-02-27
Start date
2014-09-23
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 in youth. A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and

Interventions

Intervention 1: intervention goup are randomly allocates in to lithium (1-1/2meq/lit)+tamoxifen(40mg/day)(Group A)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Ch
Treatment - Drugs
intervention goup are randomly allocates in to lithium (1-1/2meq/lit)+tamoxifen(40mg/day)(Group A)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion In
Control goup are randomly allocates into lithium (1-1/2meq/lit)+placebo(Group B)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 22 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria Consistent 9-22 years old with current manic episode (with or without psychotic feature) as diagnosed by means of the structured clinical interview for Axis I DSM-IV disorders-Patient version (SCDI-P).A score of at least 20 points on the Young Mania Rating Scale was required representing at least a moderate-to- severe mania. Exclushon Criteria: Neurological or other medical impairement- The need for ongoing treatment with other psychoactive medications and/or current substance dependence- Mental Retardation (IQ<70)- History of renal or liver function impairements- History of coagulopathy,

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Young Mania Rating Scale. Timepoint: First Week-Second Week-Third Week. Method of measurement: Questionair.

Secondary

MeasureTime frame
Child Depression Rating Scale. Timepoint: First Week-Second Week- Third Week. Method of measurement: Questionair.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Fallah

Isfahan University of Medical Seiences

elhamfallah51@yahoo.com+98 31 3668 1836

Outcome results

None listed

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