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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00206544

Registration number

NCT00206544

Ethics application status

Date submitted

13/09/2005

Date registered

21/09/2005

Date last updated

24/10/2008

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

03T-415

Secondary ID [2]

APRC 77/02

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bipolar Disorder

Mania

Schizoaffective Disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Mental Health

Psychosis and personality disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Tamoxifen
Treatment: Drugs - Progesterone
Other interventions - placebo

Active comparator: 1 - Tamoxifen 40 mg daily

Active comparator: 2 - Progesterone 20 mg daily

Placebo comparator: 3 - Placebo daily

Treatment: Drugs: Tamoxifen
40 mg daily of adjunctive tamoxifen in oral capsule

Treatment: Drugs: Progesterone
20 mg daily of adjunctive progesterone in oral capsule

Other interventions: placebo
adjunctive placebo daily in oral capsule

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Scores on CARS-M Scale at trial completion

Timepoint [1]

Baseline and weeks 1, 2, 3 and 4

Secondary outcome [1]

Scores on PANSS at trial completion (4 weeks)

Timepoint [1]

Baseline and weeks 1, 2, 3 and 4

Secondary outcome [2]

Scores on MADRS at trial completion (4 weeks)

Timepoint [2]

Baseline and weeks 1, 2, 3 and 4

Secondary outcome [3]

Scores on Adverse Symptom Checklist at trial completion (4 weeks)

Timepoint [3]

Baseline and weeks 1, 2, 3 and 4

Secondary outcome [4]

Change in hormone levels over trial duration

Timepoint [4]

Baseline and weeks 1, 2, 3 and 4

Secondary outcome [5]

Scores on RBANS at trial completion (4 weeks)

Timepoint [5]

Baseline and week 4

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

No

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2004

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/12/2007

Sample size

Target

Accrual to date

Final

51

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Bayside Health - The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

The Alfred

Address

Country

Other collaborator category [1]

Other

Name [1]

Stanley Medical Research Institute

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

National Health and Medical Research Council, Australia

Address [2]

Country [2]

Ethics approval

Ethics application status

Summary

Brief summary

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).

Trial website

https://clinicaltrials.gov/study/NCT00206544

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD

Address

Bayside Health / Monash University

Country

Phone

Fax

Email

Contact person for public queries

Name

Address

Country

Phone

Fax

Email

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00206544