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Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00206544
First received: September 13, 2005
Last updated: October 23, 2008
Last verified: October 2008
  Purpose

OBJECTIVE:

To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania.

HYPOTHESIS:

That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo.

STUDY POPULATION:

Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association.

STUDY MEDICATION:

Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm.

Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen.

Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone.

STUDY EVALUATIONS:

Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed:

  • Psychiatric evaluation to determine diagnosis. (Baseline visit only)
  • General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only)
  • Medication history (baseline and evaluation visits).
  • Demographics (baseline visits only).
  • Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit.
  • Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits).
  • Inclusion/exclusion checklist (baseline visit only).
  • Informed consent (baseline visit only).

Condition Intervention Phase
Bipolar Disorder
Mania
Schizoaffective Disorder
Drug: Tamoxifen
Drug: Progesterone
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Scores on CARS-M Scale at trial completion [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]

Secondary Outcome Measures:
  • Scores on PANSS at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
  • Scores on MADRS at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
  • Scores on Adverse Symptom Checklist at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
  • Change in hormone levels over trial duration [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
  • Scores on RBANS at trial completion (4 weeks) [ Time Frame: Baseline and week 4 ]

Enrollment: 51
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tamoxifen 40 mg daily
Drug: Tamoxifen
40 mg daily of adjunctive tamoxifen in oral capsule
Active Comparator: 2
Progesterone 20 mg daily
Drug: Progesterone
20 mg daily of adjunctive progesterone in oral capsule
Placebo Comparator: 3
Placebo daily
Other: placebo
adjunctive placebo daily in oral capsule

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients who have a current diagnosis of Bipolar Affective Disorder (Manic phase) or Schizoaffective Disorder (Bipolar type in manic phase).
  • Female patients who are able to give informed consent.

Exclusion Criteria:

  • Female patients who are pregnant or lactating.
  • Female patients with postpartum psychosis or related disorder.
  • Female patients with known abnormalities in the hypothalamo-pituitary gonadal-axis, thyroid dysfunction, central nervous system tumors.
  • Female patients taking estrogen preparations such as the oral contraceptive pill.
  • Female patients currently taking interacting drugs including warfarin, aminoglutethimide, diuretics, methyldopa, theophylline, fluoxetine, calcium channel blockers and non-steroidal anti-inflammatory drugs.
  • Female patients whose psychotic illness is directly due to illicit drugs or who have a history of substance abuse or dependence during the last 6 months.
  • Females with any significant unstable medical illness such as cardiovascular disease, renal disease, Addisons disease, thromboembolic disorders, epilepsy, diabetes etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206544

Locations
Australia, Victoria
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD Bayside Health / Monash University
  More Information

No publications provided

Responsible Party: Professory Jayashri Kulkarni, Alfred Psychiatry Research Centre
ClinicalTrials.gov Identifier: NCT00206544     History of Changes
Other Study ID Numbers: APRC 77/02, 03T-415, 284319
Study First Received: September 13, 2005
Last Updated: October 23, 2008
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Alfred:
Bipolar Affective Disorder
Mania
Anti-Estrogen
Schizoaffective Disorder
Mood

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Genetic Diseases, X-Linked
Mood Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Genetic Diseases, Inborn
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Progesterone
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014